Job DescriptionJob Description Interested in Applying? I have a few preliminary questions. Do you enjoy finding ways to make processes more efficient, consistent, and effective? Do you like investigating problems, identifying root causes, and developing practical solutions? Do you enjoy organizing documents, records, and information so they are accurate and audit-ready? Do you like using data and metrics to identify trends and improvement opportunities? Do you enjoy helping others understand and follow quality standards and procedures? Are you energized by collaborating across teams to strengthen performance and drive continual improvement? If you answered "yes" to most of these, keep reading on. Why is this Different from other Job Opportunities? This position directly supports a global, mission-critical quality program within the Department of State. The successful candidate will work across geographic locations and business units to strengthen documented processes, audit readiness, customer focus, performance measurement, and continual improvement in financial operations that support U.S. diplomacy worldwide. All contractors supporting this Department must be able to either possess or obtain a Security Clearance of Secret. You Must Meet these Minimum Requirements: Bachelor's degree from an accredited college or university in finance, economics, business administration or a closely related field. At least four years of relevant professional experience supporting an ISO 9001 quality management system. Must possess or obtain ISO 9001 Lead Internal Auditor Certification within one year of employment. Demonstrated ability to analyze complex requirements, identify risks or gaps, and develop practical alternative solutions. Excellent technical writing, proofreading, presentation, communication, and computer skills. Professional communication and collaboration supporting executive-level personnel, customers, auditors, process owners, and cross-functional teams. Preferred Experience: Hands-on experience with corrective action, root cause analysis, risk and opportunity management, and verification of corrective action effectiveness. Experience developing performance metrics, workbooks, reports, or dashboards and presenting findings to management. Project-management experience; Project Management Professional (PMP) certification (preferred but not required) Experience supporting ISO 9001 internal and external audits, certification maintenance, surveillance activities, and audit readiness. CGFS Knowledge Base experience is preferred. Salesforce experience is preferred. Our most Successful Employees in this Position Demonstrate: Analytical curiosity and disciplined attention to detail. Sound judgment, integrity, and respect for controlled information and documented processes. Diplomacy and confidence when challenging and communicating ineffective processes. Initiative, accountability, and the ability to manage multiple priorities and deadlines. A collaborative, customer-focused mindset and a commitment to measurable improvement. Overview of Department: Enterprise Financial Operations provides high-performing financial services to a global customer base. Its accounting, disbursing, and payroll operations are essential to diplomatic programs and operations in the United States and overseas. The CGFS Quality Management System (QMS) establishes the framework for consistent processes, controlled documentation, performance evaluation, internal auditing, corrective action, risk management, customer focus, and continual improvement across participating offices. Day-to-day Job Responsibilities include: Manage QMS document control, including conducting regular document-control check-ins and reviewing, revising, and maintaining the Quality Manual, Quality Work Instructions, Reference Documents, Standard Operating Procedures, master lists of core processes and QWIs reviewed during audits, and related quality records. Provide ongoing support for document management systems, including user access, reporting, troubleshooting, and guidance. Coordinate onboarding for new Quality Representatives and employees, including system access, orientation materials, organizational information, distribution lists, training resources, and required records. Develop, test, maintain, and deliver QMS training, competency modules, and user guidance for technical and nontechnical audiences. Coordinate monthly performance reviews, maintain metric workbooks and dashboards, track approved changes, analyze trends, and translate findings into actionable recommendations for management. Support management review meetings by coordinating materials, documenting decisions and action items, preparing accurate minutes, and monitoring follow-through. Plan, schedule, coordinate and support the ISO 9001 internal audit program, serve as a Supporting Auditor, as assigned; document objective evidence and findings, and maintain required audit records. Support external audits, surveillance activities, and certification readiness through evidence coordination, readiness reviews, employee awareness, and audit preparation communications. Review and approve Corrective Action Reports and Corrective Action Plans, provide guidance on root cause analysis and proposed actions, monitor progress, and verify successful implementation and closure. Maintain registers for actions, risks, opportunities, and external providers while monitoring mitigation efforts and required follow-up. Support QMS implementation and continuous improvement across CGFS business units, including offices working toward ISO 9001 certification. Map, analyze, improve, and document business processes; identify gaps, inefficiencies, risks, and control weaknesses; and develop practical, cost-conscious solutions. Prepare clear and accurate reports, presentations, meeting minutes, surveys, memoranda, and other QMS communications. Contribute to cross-functional projects by assessing requirements, developing work plans, managing deliverables, collaborating with stakeholders, and meeting established deadlines. Work Schedule: Standard 8-hour shift scheduled between 6:00 a.m. and 6:00 p.m., with a 45-minute non-compensated lunch; specific hours are coordinated with the Project Manager. Additional hours may be required with prior Project Manager and Department of State management approval. This is a 100% on-site position in Charleston, South Carolina. Up to 20% domestic and overseas travel may be required. Software Systems Utilized: Microsoft 365: intermediate-to-advanced proficiency in Word and Excel; proficiency in Teams, PowerPoint, Outlook, SharePoint, and Forms. Process, reporting, and workflow tools: Visio, Power BI, and Power Automate are desired. Document and collaboration tools: Adobe Acrobat and enterprise document-management or knowledge-base platforms. Required Training or Certification: Must possess or obtain ISO 9001 Lead Internal Auditor certification within one year of employment.
09/25/2026
Full time
Job DescriptionJob Description Interested in Applying? I have a few preliminary questions. Do you enjoy finding ways to make processes more efficient, consistent, and effective? Do you like investigating problems, identifying root causes, and developing practical solutions? Do you enjoy organizing documents, records, and information so they are accurate and audit-ready? Do you like using data and metrics to identify trends and improvement opportunities? Do you enjoy helping others understand and follow quality standards and procedures? Are you energized by collaborating across teams to strengthen performance and drive continual improvement? If you answered "yes" to most of these, keep reading on. Why is this Different from other Job Opportunities? This position directly supports a global, mission-critical quality program within the Department of State. The successful candidate will work across geographic locations and business units to strengthen documented processes, audit readiness, customer focus, performance measurement, and continual improvement in financial operations that support U.S. diplomacy worldwide. All contractors supporting this Department must be able to either possess or obtain a Security Clearance of Secret. You Must Meet these Minimum Requirements: Bachelor's degree from an accredited college or university in finance, economics, business administration or a closely related field. At least four years of relevant professional experience supporting an ISO 9001 quality management system. Must possess or obtain ISO 9001 Lead Internal Auditor Certification within one year of employment. Demonstrated ability to analyze complex requirements, identify risks or gaps, and develop practical alternative solutions. Excellent technical writing, proofreading, presentation, communication, and computer skills. Professional communication and collaboration supporting executive-level personnel, customers, auditors, process owners, and cross-functional teams. Preferred Experience: Hands-on experience with corrective action, root cause analysis, risk and opportunity management, and verification of corrective action effectiveness. Experience developing performance metrics, workbooks, reports, or dashboards and presenting findings to management. Project-management experience; Project Management Professional (PMP) certification (preferred but not required) Experience supporting ISO 9001 internal and external audits, certification maintenance, surveillance activities, and audit readiness. CGFS Knowledge Base experience is preferred. Salesforce experience is preferred. Our most Successful Employees in this Position Demonstrate: Analytical curiosity and disciplined attention to detail. Sound judgment, integrity, and respect for controlled information and documented processes. Diplomacy and confidence when challenging and communicating ineffective processes. Initiative, accountability, and the ability to manage multiple priorities and deadlines. A collaborative, customer-focused mindset and a commitment to measurable improvement. Overview of Department: Enterprise Financial Operations provides high-performing financial services to a global customer base. Its accounting, disbursing, and payroll operations are essential to diplomatic programs and operations in the United States and overseas. The CGFS Quality Management System (QMS) establishes the framework for consistent processes, controlled documentation, performance evaluation, internal auditing, corrective action, risk management, customer focus, and continual improvement across participating offices. Day-to-day Job Responsibilities include: Manage QMS document control, including conducting regular document-control check-ins and reviewing, revising, and maintaining the Quality Manual, Quality Work Instructions, Reference Documents, Standard Operating Procedures, master lists of core processes and QWIs reviewed during audits, and related quality records. Provide ongoing support for document management systems, including user access, reporting, troubleshooting, and guidance. Coordinate onboarding for new Quality Representatives and employees, including system access, orientation materials, organizational information, distribution lists, training resources, and required records. Develop, test, maintain, and deliver QMS training, competency modules, and user guidance for technical and nontechnical audiences. Coordinate monthly performance reviews, maintain metric workbooks and dashboards, track approved changes, analyze trends, and translate findings into actionable recommendations for management. Support management review meetings by coordinating materials, documenting decisions and action items, preparing accurate minutes, and monitoring follow-through. Plan, schedule, coordinate and support the ISO 9001 internal audit program, serve as a Supporting Auditor, as assigned; document objective evidence and findings, and maintain required audit records. Support external audits, surveillance activities, and certification readiness through evidence coordination, readiness reviews, employee awareness, and audit preparation communications. Review and approve Corrective Action Reports and Corrective Action Plans, provide guidance on root cause analysis and proposed actions, monitor progress, and verify successful implementation and closure. Maintain registers for actions, risks, opportunities, and external providers while monitoring mitigation efforts and required follow-up. Support QMS implementation and continuous improvement across CGFS business units, including offices working toward ISO 9001 certification. Map, analyze, improve, and document business processes; identify gaps, inefficiencies, risks, and control weaknesses; and develop practical, cost-conscious solutions. Prepare clear and accurate reports, presentations, meeting minutes, surveys, memoranda, and other QMS communications. Contribute to cross-functional projects by assessing requirements, developing work plans, managing deliverables, collaborating with stakeholders, and meeting established deadlines. Work Schedule: Standard 8-hour shift scheduled between 6:00 a.m. and 6:00 p.m., with a 45-minute non-compensated lunch; specific hours are coordinated with the Project Manager. Additional hours may be required with prior Project Manager and Department of State management approval. This is a 100% on-site position in Charleston, South Carolina. Up to 20% domestic and overseas travel may be required. Software Systems Utilized: Microsoft 365: intermediate-to-advanced proficiency in Word and Excel; proficiency in Teams, PowerPoint, Outlook, SharePoint, and Forms. Process, reporting, and workflow tools: Visio, Power BI, and Power Automate are desired. Document and collaboration tools: Adobe Acrobat and enterprise document-management or knowledge-base platforms. Required Training or Certification: Must possess or obtain ISO 9001 Lead Internal Auditor certification within one year of employment.
Requisition ID: req436 Location: Phoenix, AZ, United States Join Our Team! We are currently recruiting a Remote OPS Center Manager to join our team and contribute to key projects in a dynamic and collaborative environment. This role is part of a global team working towardcommon goals. We operate as one company, across all locations, with shared responsibility andclear accountability. The Remote Operations Center (ROC) Manager leads a team of operators across rotating 24/7 shifts, providing real-time oversight of a multi-technology renewable energy portfolio spanning wind, battery energy storage systems (BESS), and utility-scale solar photovoltaic (PV) assets. The portfolio is currently concentrated in the US Southwest (CAISO market), with planned expansion into MISO and ERCOT, and includes wind assets in Alberta and Québec with future MISO expansion. The Manager ensures safe, reliable, and compliant operations across all assets, serves as the primary escalation point for real-time operational issues, and fosters a culture of continuous improvement within the ROC. This role is pivotal in bridging field operations, scheduling coordination, asset management, and SCADA-driven alarm management. In addition, the Manager will serve as a key contributor in the stand-up of a new ROC facility launching January 1, 2027, with significant hands-on involvement throughout the first three months of operations to ensure the center is fully staffed, operationally ready, and performing to standard. Key Responsibilities Team Supervision & Shift Management Supervise, mentor, and develop a team of ROC Operators working rotating 24/7 shifts, including days, nights, weekends, and holidays. Create and maintain shift schedules ensuring continuous coverage with no single points of failure. Conduct regular performance reviews, one-on-ones, and skills assessments to support operator development and retention. Establish and enforce Standard Operating Procedures (SOPs), escalation protocols, and shift handover standards. Serve as the primary escalation contact for operators during complex or high-impact operational events. Real-Time Operations Monitoring Oversee continuous real-time monitoring of wind, BESS, and PV assets via SCADA platforms across multiple geographic regions and regulatory markets. Ensure operators actively track generation performance, equipment status, and market signals for CAISO, MISO, ERCOT, AESO, and HQÉI interconnected assets. Direct real-time responses to curtailments, forced outages, grid emergencies, and market dispatch instructions. Ensure compliance with market rules, grid codes, and interconnection agreements across all operating jurisdictions . SCADA Alarm Management Oversee the team's systematic monitoring, triage, and resolution of SCADA alarms across the full asset portfolio. Ensure alarm events are correctly classified, escalated, and documented in accordance with established alarm management procedures. Direct operators to initiate SAP Work Orders for field technician dispatch in response to equipment alarms, faults, and performance deviations. Review alarm logs and Work Order completion rates; identify recurring issues and drive root cause analysis efforts with O&M engineering teams. Champion continuous improvement of alarm rationalization and suppression strategies to reduce nuisance alarms and increase operator effectiveness. Coordination with Field Operations Serve as the primary ROC interface with field operators and site technicians at wind, BESS, and PV facilities. Oversee daily coordination of operations and maintenance (O&M) activities, ensuring safe system states and Lock Out / Tag Out (LOTO) compliance before and after field work. Authorize and document switching operations, clearances, and equipment isolation in coordination with field supervisors. Ensure the ROC team maintains accurate and up-to-date awareness of field crew activities, planned work, and site access conditions. Outage Coordination & Scheduling Lead ROC coordination of planned and forced outages with scheduling coordinators and market operators (CAISO, MISO, ERCOT, AESO, HQÉI). Ensure timely and accurate submission of outage notifications, availability updates, and return-to-service confirmations to applicable ISOs and utilities. Collaborate with asset managers, O&M teams, and commercial schedulers to minimize revenue impact and optimize outage windows. Maintain outage logs and ensure compliance with reporting timelines required by each market and regulatory jurisdiction . SAP Work Order Administration Ensure ROC operators proficiently create, assign, and close SAP Plant Maintenance (PM) Work Orders in response to SCADA alarms and operational events Monitor Work Order backlogs and escalate aging or high-priority items to maintenance supervisors and asset managers. Review and approve Work Orders for accuracy, completeness, and appropriate priority classification. Participate in weekly O&M planning meetings to align ROC-generated Work Orders with field maintenance schedules. Reporting & Documentation Ensure accurate shift logs, incident reports, and operational summaries are produced for every shift. Prepare and deliver daily, weekly, and monthly operational performance reports to leadership. Track and report KPIs including asset availability, alarm response time, Work Order cycle time, and outage duration. Support post-event investigations and document lessons learned to prevent recurrence. ROC Stand-Up & New Facility Commissioning Work as a key contributor alongside the project team to stand up a new Remote Operations Center launching January 1, 2027, with primary focus and elevated involvement expected through March 31, 2027. Contribute to the design and implementation of ROC operational infrastructure, including SCADA integration, alarm management frameworks, and workstation configuration. Assist in recruiting, onboarding, and initial training of ROC Operators for the new facility, ensuring all personnel are shift-ready prior to go-live. Develop and validate Standard Operating Procedures, shift handover standards, escalation protocols, and emergency response plans tailored to the new facility's asset portfolio. Coordinate with IT, SCADA/controls vendors, and O&M engineering teams to resolve integration issues and confirm system readiness before and during commissioning. Participate in tabletop exercises, mock-shift walkthroughs, and operational readiness reviews to verify the team and systems are prepared for live operations. Track and report stand-up milestones, open action items, and readiness gaps to project leadership throughout the commissioning period. Transition stand-up responsibilities to steady-state operations management no later than the end of Q1 2027, maintaining documentation of lessons learned for future facility launches. Qualifications Required Bachelor's degree in electrical engineering , p ower s ystems, e nergy m anagement, or a related technical field - OR equivalent combination of education and experience. Minimum 10 years of experience in ROC renewable power plant operations, grid control room operations, or utility/ISO operations. Minimum 5 years in a managerial role within a 24/7 operational environment. Demonstrated experience with SCADA platforms in a wind, solar, or BESS operations environment. Familiarity with SAP Plant Maintenance (PM) module for Work Order creation and management. Understanding of wholesale electricity markets and interconnection requirements in at least one of: CAISO, MISO, ERCOT, AESO, or HQÉI. Strong working knowledge of safety protocols including LOTO, switching procedures, and high-voltage safety practices. Excellent leadership, communication, and team development skills. Preferred Experience operating across multiple ISOs/markets simultaneously, particularly CAISO and Canadian markets (AESO / HQÉI). Familiarity with all three asset classes: wind turbine generators, utility-scale PV inverters, and grid-scale BESS systems. Knowledge of NERC/WECC reliability standards and Canadian provincial grid codes applicable to renewable generation. Experience with energy management systems (EMS) and/or advanced SCADA historian platforms (e.g., OSIsoft PI, GE Predix, or similar). Professional certification: NERC System Operator Certification, PE license, or equivalent market certification. Bilingual (English/French , English/Spanish ). Core Competencies Operational Leadership Technical Acumen Team coaching & performance management Decision-making under pressure Effective escalation & communication Process discipline & SOP adherence SCADA alarm management & triage Multi-market regulatory knowledge SAP PM Work Order proficiency Wind, PV & BESS systems knowledge Working Conditions Primary work location: Tempe, Arizona ROC facility (on-site required ). 24/7 operational environment; manager must be available for escalation on-call outside of standard shifts. Sporadic travel to field sites in US Southwest (AZ, CA, NM, NV), Alberta (Canada), and Québec (Canada) may be required . . click apply for full job details
09/25/2026
Full time
Requisition ID: req436 Location: Phoenix, AZ, United States Join Our Team! We are currently recruiting a Remote OPS Center Manager to join our team and contribute to key projects in a dynamic and collaborative environment. This role is part of a global team working towardcommon goals. We operate as one company, across all locations, with shared responsibility andclear accountability. The Remote Operations Center (ROC) Manager leads a team of operators across rotating 24/7 shifts, providing real-time oversight of a multi-technology renewable energy portfolio spanning wind, battery energy storage systems (BESS), and utility-scale solar photovoltaic (PV) assets. The portfolio is currently concentrated in the US Southwest (CAISO market), with planned expansion into MISO and ERCOT, and includes wind assets in Alberta and Québec with future MISO expansion. The Manager ensures safe, reliable, and compliant operations across all assets, serves as the primary escalation point for real-time operational issues, and fosters a culture of continuous improvement within the ROC. This role is pivotal in bridging field operations, scheduling coordination, asset management, and SCADA-driven alarm management. In addition, the Manager will serve as a key contributor in the stand-up of a new ROC facility launching January 1, 2027, with significant hands-on involvement throughout the first three months of operations to ensure the center is fully staffed, operationally ready, and performing to standard. Key Responsibilities Team Supervision & Shift Management Supervise, mentor, and develop a team of ROC Operators working rotating 24/7 shifts, including days, nights, weekends, and holidays. Create and maintain shift schedules ensuring continuous coverage with no single points of failure. Conduct regular performance reviews, one-on-ones, and skills assessments to support operator development and retention. Establish and enforce Standard Operating Procedures (SOPs), escalation protocols, and shift handover standards. Serve as the primary escalation contact for operators during complex or high-impact operational events. Real-Time Operations Monitoring Oversee continuous real-time monitoring of wind, BESS, and PV assets via SCADA platforms across multiple geographic regions and regulatory markets. Ensure operators actively track generation performance, equipment status, and market signals for CAISO, MISO, ERCOT, AESO, and HQÉI interconnected assets. Direct real-time responses to curtailments, forced outages, grid emergencies, and market dispatch instructions. Ensure compliance with market rules, grid codes, and interconnection agreements across all operating jurisdictions . SCADA Alarm Management Oversee the team's systematic monitoring, triage, and resolution of SCADA alarms across the full asset portfolio. Ensure alarm events are correctly classified, escalated, and documented in accordance with established alarm management procedures. Direct operators to initiate SAP Work Orders for field technician dispatch in response to equipment alarms, faults, and performance deviations. Review alarm logs and Work Order completion rates; identify recurring issues and drive root cause analysis efforts with O&M engineering teams. Champion continuous improvement of alarm rationalization and suppression strategies to reduce nuisance alarms and increase operator effectiveness. Coordination with Field Operations Serve as the primary ROC interface with field operators and site technicians at wind, BESS, and PV facilities. Oversee daily coordination of operations and maintenance (O&M) activities, ensuring safe system states and Lock Out / Tag Out (LOTO) compliance before and after field work. Authorize and document switching operations, clearances, and equipment isolation in coordination with field supervisors. Ensure the ROC team maintains accurate and up-to-date awareness of field crew activities, planned work, and site access conditions. Outage Coordination & Scheduling Lead ROC coordination of planned and forced outages with scheduling coordinators and market operators (CAISO, MISO, ERCOT, AESO, HQÉI). Ensure timely and accurate submission of outage notifications, availability updates, and return-to-service confirmations to applicable ISOs and utilities. Collaborate with asset managers, O&M teams, and commercial schedulers to minimize revenue impact and optimize outage windows. Maintain outage logs and ensure compliance with reporting timelines required by each market and regulatory jurisdiction . SAP Work Order Administration Ensure ROC operators proficiently create, assign, and close SAP Plant Maintenance (PM) Work Orders in response to SCADA alarms and operational events Monitor Work Order backlogs and escalate aging or high-priority items to maintenance supervisors and asset managers. Review and approve Work Orders for accuracy, completeness, and appropriate priority classification. Participate in weekly O&M planning meetings to align ROC-generated Work Orders with field maintenance schedules. Reporting & Documentation Ensure accurate shift logs, incident reports, and operational summaries are produced for every shift. Prepare and deliver daily, weekly, and monthly operational performance reports to leadership. Track and report KPIs including asset availability, alarm response time, Work Order cycle time, and outage duration. Support post-event investigations and document lessons learned to prevent recurrence. ROC Stand-Up & New Facility Commissioning Work as a key contributor alongside the project team to stand up a new Remote Operations Center launching January 1, 2027, with primary focus and elevated involvement expected through March 31, 2027. Contribute to the design and implementation of ROC operational infrastructure, including SCADA integration, alarm management frameworks, and workstation configuration. Assist in recruiting, onboarding, and initial training of ROC Operators for the new facility, ensuring all personnel are shift-ready prior to go-live. Develop and validate Standard Operating Procedures, shift handover standards, escalation protocols, and emergency response plans tailored to the new facility's asset portfolio. Coordinate with IT, SCADA/controls vendors, and O&M engineering teams to resolve integration issues and confirm system readiness before and during commissioning. Participate in tabletop exercises, mock-shift walkthroughs, and operational readiness reviews to verify the team and systems are prepared for live operations. Track and report stand-up milestones, open action items, and readiness gaps to project leadership throughout the commissioning period. Transition stand-up responsibilities to steady-state operations management no later than the end of Q1 2027, maintaining documentation of lessons learned for future facility launches. Qualifications Required Bachelor's degree in electrical engineering , p ower s ystems, e nergy m anagement, or a related technical field - OR equivalent combination of education and experience. Minimum 10 years of experience in ROC renewable power plant operations, grid control room operations, or utility/ISO operations. Minimum 5 years in a managerial role within a 24/7 operational environment. Demonstrated experience with SCADA platforms in a wind, solar, or BESS operations environment. Familiarity with SAP Plant Maintenance (PM) module for Work Order creation and management. Understanding of wholesale electricity markets and interconnection requirements in at least one of: CAISO, MISO, ERCOT, AESO, or HQÉI. Strong working knowledge of safety protocols including LOTO, switching procedures, and high-voltage safety practices. Excellent leadership, communication, and team development skills. Preferred Experience operating across multiple ISOs/markets simultaneously, particularly CAISO and Canadian markets (AESO / HQÉI). Familiarity with all three asset classes: wind turbine generators, utility-scale PV inverters, and grid-scale BESS systems. Knowledge of NERC/WECC reliability standards and Canadian provincial grid codes applicable to renewable generation. Experience with energy management systems (EMS) and/or advanced SCADA historian platforms (e.g., OSIsoft PI, GE Predix, or similar). Professional certification: NERC System Operator Certification, PE license, or equivalent market certification. Bilingual (English/French , English/Spanish ). Core Competencies Operational Leadership Technical Acumen Team coaching & performance management Decision-making under pressure Effective escalation & communication Process discipline & SOP adherence SCADA alarm management & triage Multi-market regulatory knowledge SAP PM Work Order proficiency Wind, PV & BESS systems knowledge Working Conditions Primary work location: Tempe, Arizona ROC facility (on-site required ). 24/7 operational environment; manager must be available for escalation on-call outside of standard shifts. Sporadic travel to field sites in US Southwest (AZ, CA, NM, NV), Alberta (Canada), and Québec (Canada) may be required . . click apply for full job details
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
MENTOR TECHNICAL GROUP CORP
Grand Rapids, Michigan
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
MENTOR TECHNICAL GROUP CORP
Bakersfield, California
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
MENTOR TECHNICAL GROUP CORP
New Orleans, Louisiana
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
MENTOR TECHNICAL GROUP CORP
Pittsfield, Massachusetts
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
09/25/2026
Full time
Job DescriptionJob Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.