About Us Visa is a world leader in payments technology, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and territories, dedicated to uplifting everyone, everywhere by being the best way to pay and be paid. At Visa, you'll have the opportunity to create impact at scale - tackling meaningful challenges, growing your skills and seeing your contributions impact lives around the world. Join Visa and do work that matters - to you, to your community, and to the world. Progress starts with you. Job Description A Senior Data Engineer at Visa plays a pivotal role within a cross-disciplined agile team, contributing to the product backlog and delivering critical features to enhance data presentation for customers and engineering teams. This position involves driving improvements to processes and practices, providing technical leadership, and mentoring others. The role requires dedication to technical excellence in code writing, team collaboration, testing, and documentation. Senior Data Engineers work alongside intermediate and senior engineers, agile team members, and consultants, demonstrating strong communication skills and a willingness to collaborate across disciplines as needed. All roles require digital fluency, including the ability to work with emerging technologies such as Generative AI tools (e.g. ChatGPT, Microsoft Copilot) to support everyday work. Key Responsibilities: Collaborate with stakeholders to determine requirements for product components and incorporate feedback into future designs or solution fixes. Translate functional requirements into system designs and communicate component interactions. Design and develop product components, refine code plans for architecture, and lead design reviews. Participate in project estimation and review product estimations, considering delivery costs and escalating issues as needed. Lead by example and mentor others in creating extensible, maintainable, and reusable code. Apply debugging tools to address moderately complex issues and identify opportunities for automation. Lead code reviews to ensure coding standards and best practices are followed. Create complex test plans, identify tools, prioritize tests, and interpret test results to inform planning. Proactively identify and contain defects in software code to minimize customer impact and share findings with stakeholders across product features. Visa requires at least 3 days in office, expectations of these days will be confirmed by your Hiring Manager. Qualifications Basic Qualifications: 8 or more years of relevant work experience with a Bachelor Degree or at least 5 years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 2 years of work experience with a PhD Preferred Qualifications: 9 or more years of relevant work experience with a Bachelor Degree or 7 or more relevant years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 3 or more years of experience with a PhD Expert-level experience with the Spark framework, Hive-based technologies, and broader Big Data development tools and platforms. 5+ years of hands-on programming experience in Java, Scala, or Python, with the ability to quickly develop clean, production-quality prototypes and core application components. Practical experience applying Generative AI and Large Language Models in data engineering, including leading initiatives that leverage GenAI to improve team productivity and operational efficiency. Strong working knowledge of SQL, NoSQL, graph databases, and RESTful APIs. Demonstrated success leading large-scale, end-to-end projects that deliver measurable business impact, from initial concept through production delivery. Strong understanding of algorithms, data structures, and core computer science fundamentals. Practical experience with data modeling for both relational and non-relational database systems. Experience collaborating with data scientists and machine learning teams, with the ability to discuss major machine learning paradigms, algorithms, and common software tools. Hands-on experience designing, building, and managing reliable data pipelines that move data across systems using tools such as Apache Airflow. Proficiency with version control systems such as Git, along with experience implementing CI/CD pipelines for automated testing, deployment, and release management. Demonstrated leadership behaviors, including a positive mindset, quick learning ability, collaboration, courage in leadership, and strong customer obsession. Experience in mentoring junior engineers and providing technical leadership. Experience in refining code plans for architecture and sharing learnings with the team. Experience in driving security assessment processes to ensure code quality. Experience in collaborating with cross-functional teams to deliver solutions. Ability to manage multiple, competing priorities effectively in a fast-paced, dynamic environment. Experience supporting data quality, data lineage, data governance, compliance, and security requirements within data engineering environments. Information for US Applicants For roles located in the US, the estimated salary range for this position is $180,600.00 to $ 289,300.00 USD per year, which may include potential sales incentive payments (if applicable). Salary may vary depending on job-related factors which may include knowledge, skills, experience, and location. In addition, this position may be eligible for bonus and equity.Visa has a comprehensive benefits package for which this position may be eligible that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness Program. Work Hours Varies upon the needs of the department. Travel Requirements This position requires travel 5-10% of the time. Mental/Physical Requirements This position will be performed in an office setting. The position will require the incumbent to sit and stand at a desk, communicate in person and by telephone, frequently operate standard office equipment, such as telephones and computers. Visa is an EEO Employer Qualified applicants will receive consideration for employment without regard to race, color religion, sex, national origin, sexual orientation, gender identity, disability or protect veteran status. Visa will also consider for employment qualified applicants with criminal histories in a manner consistent with the EEOC guidelines and applicable local law.
09/26/2026
Full time
About Us Visa is a world leader in payments technology, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and territories, dedicated to uplifting everyone, everywhere by being the best way to pay and be paid. At Visa, you'll have the opportunity to create impact at scale - tackling meaningful challenges, growing your skills and seeing your contributions impact lives around the world. Join Visa and do work that matters - to you, to your community, and to the world. Progress starts with you. Job Description A Senior Data Engineer at Visa plays a pivotal role within a cross-disciplined agile team, contributing to the product backlog and delivering critical features to enhance data presentation for customers and engineering teams. This position involves driving improvements to processes and practices, providing technical leadership, and mentoring others. The role requires dedication to technical excellence in code writing, team collaboration, testing, and documentation. Senior Data Engineers work alongside intermediate and senior engineers, agile team members, and consultants, demonstrating strong communication skills and a willingness to collaborate across disciplines as needed. All roles require digital fluency, including the ability to work with emerging technologies such as Generative AI tools (e.g. ChatGPT, Microsoft Copilot) to support everyday work. Key Responsibilities: Collaborate with stakeholders to determine requirements for product components and incorporate feedback into future designs or solution fixes. Translate functional requirements into system designs and communicate component interactions. Design and develop product components, refine code plans for architecture, and lead design reviews. Participate in project estimation and review product estimations, considering delivery costs and escalating issues as needed. Lead by example and mentor others in creating extensible, maintainable, and reusable code. Apply debugging tools to address moderately complex issues and identify opportunities for automation. Lead code reviews to ensure coding standards and best practices are followed. Create complex test plans, identify tools, prioritize tests, and interpret test results to inform planning. Proactively identify and contain defects in software code to minimize customer impact and share findings with stakeholders across product features. Visa requires at least 3 days in office, expectations of these days will be confirmed by your Hiring Manager. Qualifications Basic Qualifications: 8 or more years of relevant work experience with a Bachelor Degree or at least 5 years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 2 years of work experience with a PhD Preferred Qualifications: 9 or more years of relevant work experience with a Bachelor Degree or 7 or more relevant years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 3 or more years of experience with a PhD Expert-level experience with the Spark framework, Hive-based technologies, and broader Big Data development tools and platforms. 5+ years of hands-on programming experience in Java, Scala, or Python, with the ability to quickly develop clean, production-quality prototypes and core application components. Practical experience applying Generative AI and Large Language Models in data engineering, including leading initiatives that leverage GenAI to improve team productivity and operational efficiency. Strong working knowledge of SQL, NoSQL, graph databases, and RESTful APIs. Demonstrated success leading large-scale, end-to-end projects that deliver measurable business impact, from initial concept through production delivery. Strong understanding of algorithms, data structures, and core computer science fundamentals. Practical experience with data modeling for both relational and non-relational database systems. Experience collaborating with data scientists and machine learning teams, with the ability to discuss major machine learning paradigms, algorithms, and common software tools. Hands-on experience designing, building, and managing reliable data pipelines that move data across systems using tools such as Apache Airflow. Proficiency with version control systems such as Git, along with experience implementing CI/CD pipelines for automated testing, deployment, and release management. Demonstrated leadership behaviors, including a positive mindset, quick learning ability, collaboration, courage in leadership, and strong customer obsession. Experience in mentoring junior engineers and providing technical leadership. Experience in refining code plans for architecture and sharing learnings with the team. Experience in driving security assessment processes to ensure code quality. Experience in collaborating with cross-functional teams to deliver solutions. Ability to manage multiple, competing priorities effectively in a fast-paced, dynamic environment. Experience supporting data quality, data lineage, data governance, compliance, and security requirements within data engineering environments. Information for US Applicants For roles located in the US, the estimated salary range for this position is $180,600.00 to $ 289,300.00 USD per year, which may include potential sales incentive payments (if applicable). Salary may vary depending on job-related factors which may include knowledge, skills, experience, and location. In addition, this position may be eligible for bonus and equity.Visa has a comprehensive benefits package for which this position may be eligible that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness Program. Work Hours Varies upon the needs of the department. Travel Requirements This position requires travel 5-10% of the time. Mental/Physical Requirements This position will be performed in an office setting. The position will require the incumbent to sit and stand at a desk, communicate in person and by telephone, frequently operate standard office equipment, such as telephones and computers. Visa is an EEO Employer Qualified applicants will receive consideration for employment without regard to race, color religion, sex, national origin, sexual orientation, gender identity, disability or protect veteran status. Visa will also consider for employment qualified applicants with criminal histories in a manner consistent with the EEOC guidelines and applicable local law.
The Lead Project Manager (PM) develops and ensures consistent processes across projects, leveraging strong communication skills and knowledge of project management software. The Lead PM will demonstrate proficiency in project management tasks, strategies, and tools. They will manage process improvement projects, develop tooling and process leveraged across our program by our broader team of project managers, educate our broader project management team, and monitor compliance. They will also assist with identifying areas for process improvement. The Lead PM will be able to operate in the role largely independently within defined policies and procedures. Key Responsibilities Lead multiple complex projects and programs concurrently, prioritizing work to meet changing deadlines. Facilitate project design, integration, requirements, and decision-making meetings; establish and drive clear next steps through completion. Gather, document, analyze, and validate business and functional requirements; facilitate stakeholder review sessions. Serve as a primary point of contact for requirements, project tooling, and collateral questions from engineers, leadership, teams, clients, and other stakeholders. Conduct business analysis and provide stakeholder consultation using quantitative and qualitative data. Identify, assess, manage, and escalate project risks; lead mitigation and resolution strategies. Produce timely, high-quality project status reporting and present updates to executives and project stakeholders. Identify opportunities for process improvement; develop and implement efficient, sustainable, repeatable solutions. Guide project-management tooling and collateral-storage strategies using SharePoint sites, lists, apps, and workflows, or proactively develop this capability through self-directed learning. Ensure applicable training materials, process documentation, and project collateral remain current and accurate. Build and maintain productive internal and external stakeholder relationships in support of business objectives. Indirectly coach team members on priorities, objectives, and daily work, as needed. Basic Qualifications At least 8 years of combined completed higher education and related work experience, including at least 2 years of project-management experience in process improvement, project planning and execution, team leadership and management, stakeholder management, risk management, and project reporting and presentation. Ability to successfully complete the Federal Security Clearance process applicable to the position. Experience with process-mapping tools. Experience with, or demonstrated ability to learn through self-paced training, project-management tools such as Microsoft SharePoint sites and lists, Digital.aiAgility (VersionOne), and Confluence. Intermediate Microsoft Excel skills, including confident use of functions such as PivotTables and VLOOKUP. Strong analytical and problem-solving skills with close attention to detail and accuracy. Strong documentation skills using tools such as Microsoft PowerPoint and Microsoft Word. Ability to navigate ambiguity in project planning and delivery. Excellent written and verbal communication skills. Preferred Qualifications Experience with Oracle Health Consulting and/or Federal deployment methodology. High Level Oracle Health Product and Workflow Knowledge. Experience with Oracle Apex. Experience in healthcare information technology (HCIT) consulting. Project Management Professional (PMP) - Project Management Institute (PMI). Other Expectations Must reside in, or be willing to relocate to, an approved virtual work location. Must be a U.S. citizen. Must be willing to travel occasionally as needed. Must be willing to work additional or irregular hours as needed, consistent with local regulations. Work in accordance with corporate and organizational security policies and procedures; safeguard corporate and client assets and report potential security compromises within the scope of the role. Perform other responsibilities as assigned. Responsibilities Qualifications Disclaimer: Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements. Range and benefit information provided in this posting are specific to the stated locations only US: Hiring Range in USD from: $91,400 to $187,000 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. As part of Oracle's onboarding process and consistent with applicable law, US-based employees are required to complete identity verification, which involves the collection and processing of their biometric information. Accommodations to this requirement may be granted following an individualized assessment. Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. And with AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives. True innovation starts when everyone is empowered to contribute. That's why we're committed to growing a workforce that promotes opportunities for all with competitive benefits that support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling 1- in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
09/26/2026
Full time
The Lead Project Manager (PM) develops and ensures consistent processes across projects, leveraging strong communication skills and knowledge of project management software. The Lead PM will demonstrate proficiency in project management tasks, strategies, and tools. They will manage process improvement projects, develop tooling and process leveraged across our program by our broader team of project managers, educate our broader project management team, and monitor compliance. They will also assist with identifying areas for process improvement. The Lead PM will be able to operate in the role largely independently within defined policies and procedures. Key Responsibilities Lead multiple complex projects and programs concurrently, prioritizing work to meet changing deadlines. Facilitate project design, integration, requirements, and decision-making meetings; establish and drive clear next steps through completion. Gather, document, analyze, and validate business and functional requirements; facilitate stakeholder review sessions. Serve as a primary point of contact for requirements, project tooling, and collateral questions from engineers, leadership, teams, clients, and other stakeholders. Conduct business analysis and provide stakeholder consultation using quantitative and qualitative data. Identify, assess, manage, and escalate project risks; lead mitigation and resolution strategies. Produce timely, high-quality project status reporting and present updates to executives and project stakeholders. Identify opportunities for process improvement; develop and implement efficient, sustainable, repeatable solutions. Guide project-management tooling and collateral-storage strategies using SharePoint sites, lists, apps, and workflows, or proactively develop this capability through self-directed learning. Ensure applicable training materials, process documentation, and project collateral remain current and accurate. Build and maintain productive internal and external stakeholder relationships in support of business objectives. Indirectly coach team members on priorities, objectives, and daily work, as needed. Basic Qualifications At least 8 years of combined completed higher education and related work experience, including at least 2 years of project-management experience in process improvement, project planning and execution, team leadership and management, stakeholder management, risk management, and project reporting and presentation. Ability to successfully complete the Federal Security Clearance process applicable to the position. Experience with process-mapping tools. Experience with, or demonstrated ability to learn through self-paced training, project-management tools such as Microsoft SharePoint sites and lists, Digital.aiAgility (VersionOne), and Confluence. Intermediate Microsoft Excel skills, including confident use of functions such as PivotTables and VLOOKUP. Strong analytical and problem-solving skills with close attention to detail and accuracy. Strong documentation skills using tools such as Microsoft PowerPoint and Microsoft Word. Ability to navigate ambiguity in project planning and delivery. Excellent written and verbal communication skills. Preferred Qualifications Experience with Oracle Health Consulting and/or Federal deployment methodology. High Level Oracle Health Product and Workflow Knowledge. Experience with Oracle Apex. Experience in healthcare information technology (HCIT) consulting. Project Management Professional (PMP) - Project Management Institute (PMI). Other Expectations Must reside in, or be willing to relocate to, an approved virtual work location. Must be a U.S. citizen. Must be willing to travel occasionally as needed. Must be willing to work additional or irregular hours as needed, consistent with local regulations. Work in accordance with corporate and organizational security policies and procedures; safeguard corporate and client assets and report potential security compromises within the scope of the role. Perform other responsibilities as assigned. Responsibilities Qualifications Disclaimer: Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements. Range and benefit information provided in this posting are specific to the stated locations only US: Hiring Range in USD from: $91,400 to $187,000 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. As part of Oracle's onboarding process and consistent with applicable law, US-based employees are required to complete identity verification, which involves the collection and processing of their biometric information. Accommodations to this requirement may be granted following an individualized assessment. Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. And with AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives. True innovation starts when everyone is empowered to contribute. That's why we're committed to growing a workforce that promotes opportunities for all with competitive benefits that support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling 1- in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable 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
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.
