Crossflow Technologies
Dayton, Ohio
Job Description Job Description: Job Description Crossflow Technologies has an exciting opportunity for a Configuration Manager located in Kettering, OH (WPAFB/Dayton, OH area) to support our EPASS GB contract. As part of the AFLCMC/GB Business and Enterprise Systems Directorate (BES), the Acquisition Business Systems Branch (GBBX). All GBBX programs/applications are merging towards a Common Portal Environment (CPE), in which all programs/applications will be accessed through a central dashboard. Furthermore, GBBX is migrating. all development activities towards an agile, Dev, Sec, Ops methodology, requiring the user community and functional sponsor representatives to be "hands-on" during the development process. The Configuration Manager will provide support ranging across the Configuration Management (CM), Quality Assurance (QA), Program Planning (PP), Risk Management (RM), and System Engineering (SE) activities which will vary depending upon the current activities of the program/system, scope of the current development/sustainment cycle, and other corporate and program initiatives. The contractor shall provide resources with progressive experience in technical writing, critical thinking and analysis, managing configuration of software, engineering documents, design drawings, engineering changes and notices, and planning/conducting design audits to enable government ownership of the program technical baseline. The contractor shall provide skills and experience necessary to perform the following tasks: • Provide and maintain CM of all relevant system artifacts, e.g., documentation, source code, build files, scripts, etc., to allow the government the capability to build and release a working copy of the system to the appropriate production environment;• Archive acquisition documentation; • Review and evaluate the Development/Sustainment Contractor's CM program and data deliveries for accuracy, completeness, and compliance; • Maintain CM files including configuration identification, change control, and status accounting records; • Implement CM plans; • Participate in cross-functional change control boards meetings such as, but not limited to, Configuration Control Board (CCB), Change Control Board (CCB), Functional Review Board (FRB), Requirements Review Board (RRB), etc., to record and manage proposed and approved changes; • Review the change control boards' membership list for currency and completeness; • Support Engineering Assessments; • Prepare for, conduct, and/or support major audits such as Physical Configuration Audits (PCAs) and Functional Configuration Audits (FCAs); • Record and maintain assessment and audit findings, minutes, and action items; • Report the Development/Sustainment Contractor's required software delivery status; • Support pre- and post-contract award data reviews via meeting attendance and capturing meeting minutes; • Review and evaluate the Development/Sustainment Contractor's conformance to CDRL requirements; • Manage Government and Development/Sustainment Contractor correspondence • Support the establishment of work flows; • Ensure configuration items are properly identified and documentation is accomplished; • Track configuration item deliverables and responses; • Support development/sustainment of paper and automated archival systems of all covered documentation; • Work closely with program management, systems engineers, quality managers, draftsmen and design/manufacturing engineers in an integrated product team environment; • Develop and administer configuration management plans; • Maintain design traceability and integrity; • Convene and manage change control boards; • Assist the Government with configuration control for ERP and IT systems. This shall include configuration planning, maintenance of configuration documentation and data, and maintaining inventory/configuration status accounting; • Manage configurations of software, engineering documents, design drawings, engineering changes and notices, and planning/conducting design audits with the required skills and experience necessary to work closely with program management, systems engineers, quality managers, and design engineers in an integrated product team environment; • Support requirements and change control boards via meeting attendance and capturing meeting minutes; • Track and manage proposed and approved changes, e.g., Engineering Change Proposals (ECPs), Change Requests (CRs), and Discrepancy Reports (DRs) / Problem Reports (PRs), throughout system development & sustainment lifecycle; • Ensure integrity of the baseline including major releases, minor releases, patches, and software maintenance; • Provide QA checks on system baselines, i.e., Functional, Allocated, Product; • Support Licensing tasks and packaging and delivering of software to users; • Maintain the CM library and software repository; • Manage and control system baselines; • Recommend and document comprehensive configuration management plans for software, hardware, firmware, and peripherals for IT systems; • Evaluate data and preparing plans and briefings in support of software-driven systems; • Evaluate and monitor effectiveness of configuration management plans to identify potential and existing problems and make recommendations for resolution; • Audit and review IT system configurations for compliance to required specifications; • Control the configuration of IT systems; and/or, • Develop and manage access and change control guidelines and procedures to avoid unauthorized access and changes to system configurations. Required Qualifications: The Configuration Manager has the knowledge, experience and recognized ability to be considered highly skilled in their technical/professional field. Possesses the ability to perform tasks independently and oversee the efforts of junior and journeyman contractor personnel within the technical/professional discipline. Demonstrates advanced knowledge of their technical/professional discipline as well as possess a comprehensive understanding and ability to apply associated standards, procedures and practices in their area of expertise (Program Office, Enterprise and Staff Level Support interface). • IT Configuration Management experience within the Department of Defense environment; • Formal training and knowledge of configuration management directives, standards, principles (Plan, Identify, Control, AuditNerify, Status Accounting), and techniques; • Experience performing HW and SW configuration audits; • Experience performing the technical administrative activities necessary to manage CM tools, e.g., Git, Gitlab, Jira, Confluence, Bitbucket, AWSConfig, Azure DevOps Server, Insight, Star Team, for inventory control, version control, data duplication, media labeling; • Experience producing release notes and CM reports; • In-depth understanding of the configuration change control process, the role of the Configuration/Change Control Board, and change control documentation; • Experience performing baseline administrative activities for multiple environments; • Performing written and oral communications; • Experience developing briefings for management • Understanding of all phases of the software development life cycle; • Ability to enter and manage system configuration items in a database; • Ability to provide critical analysis in the realm of problem identification and analysis, interpretation and understanding of links between ideas, research, identification of inconsistencies and errors, relevance confirmation, explanation and presentation, creative and open mindedness, evaluation and problem-solving; • Extensive technical writing experience to provide accurate, concise, and clear document designs, collaboration, presentation, and research skills needed to design productive workplace documents and presentations for a variety of purposes and audiences; and/or, • Assist in developing and administering configuration management plans, maintaining design traceability and integrity, convening and managing change control boards, and preparing for and attending major events such as, but not limited to, TIMs, PDRs, CDRs, PCAs, FCAs, and CCBs. Candidate must be a US Citizen - REQUIRED Candidate must possess and be able to maintain a T1/NACI - REQUIRED Master's or Doctorate Degree in a related field and ten years of experience in the respective technical/professional discipline being performed, five years of which must be in the DoD OR, Bachelor's Degree in a related field and 12 years of experience in the respective technical/professional discipline being performed, five of which must be in the DoD OR, 15 years of directly related experience with proper certifications as described in the PWS labor category performance requirements, eight of which must be in the DoD. Preferred Qualifications: Possessing any of the following certifications would be beneficial, but not required: • Certification in Software Configuration Management - Desired. • Certification in Agile Development - Desired, or • Scrum Master Certification - Desired Schedule: (M-F; 8-5) Work Location: Kettering, OH (Dayton/WPAFB)- Onsite Travel: 0-10% Relocation Assistance Available: No Position Contingent Upon Award of Contract: No Equal Opportunity/Affirmative Action Employer: Crossflow ensures that employment decisions and personnel actions are administered fairly, equitably, and in compliance with the federal, state, and local laws and regulations governing EEO and personnel management. All qualified individuals will receive consideration for employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Why Crossflow? Crossflow Technologies is proud to offer such wonderful benefits and perks to our employees; however, we feel the biggest perk is our company culture . click apply for full job details
Job Description Job Description: Job Description Crossflow Technologies has an exciting opportunity for a Configuration Manager located in Kettering, OH (WPAFB/Dayton, OH area) to support our EPASS GB contract. As part of the AFLCMC/GB Business and Enterprise Systems Directorate (BES), the Acquisition Business Systems Branch (GBBX). All GBBX programs/applications are merging towards a Common Portal Environment (CPE), in which all programs/applications will be accessed through a central dashboard. Furthermore, GBBX is migrating. all development activities towards an agile, Dev, Sec, Ops methodology, requiring the user community and functional sponsor representatives to be "hands-on" during the development process. The Configuration Manager will provide support ranging across the Configuration Management (CM), Quality Assurance (QA), Program Planning (PP), Risk Management (RM), and System Engineering (SE) activities which will vary depending upon the current activities of the program/system, scope of the current development/sustainment cycle, and other corporate and program initiatives. The contractor shall provide resources with progressive experience in technical writing, critical thinking and analysis, managing configuration of software, engineering documents, design drawings, engineering changes and notices, and planning/conducting design audits to enable government ownership of the program technical baseline. The contractor shall provide skills and experience necessary to perform the following tasks: • Provide and maintain CM of all relevant system artifacts, e.g., documentation, source code, build files, scripts, etc., to allow the government the capability to build and release a working copy of the system to the appropriate production environment;• Archive acquisition documentation; • Review and evaluate the Development/Sustainment Contractor's CM program and data deliveries for accuracy, completeness, and compliance; • Maintain CM files including configuration identification, change control, and status accounting records; • Implement CM plans; • Participate in cross-functional change control boards meetings such as, but not limited to, Configuration Control Board (CCB), Change Control Board (CCB), Functional Review Board (FRB), Requirements Review Board (RRB), etc., to record and manage proposed and approved changes; • Review the change control boards' membership list for currency and completeness; • Support Engineering Assessments; • Prepare for, conduct, and/or support major audits such as Physical Configuration Audits (PCAs) and Functional Configuration Audits (FCAs); • Record and maintain assessment and audit findings, minutes, and action items; • Report the Development/Sustainment Contractor's required software delivery status; • Support pre- and post-contract award data reviews via meeting attendance and capturing meeting minutes; • Review and evaluate the Development/Sustainment Contractor's conformance to CDRL requirements; • Manage Government and Development/Sustainment Contractor correspondence • Support the establishment of work flows; • Ensure configuration items are properly identified and documentation is accomplished; • Track configuration item deliverables and responses; • Support development/sustainment of paper and automated archival systems of all covered documentation; • Work closely with program management, systems engineers, quality managers, draftsmen and design/manufacturing engineers in an integrated product team environment; • Develop and administer configuration management plans; • Maintain design traceability and integrity; • Convene and manage change control boards; • Assist the Government with configuration control for ERP and IT systems. This shall include configuration planning, maintenance of configuration documentation and data, and maintaining inventory/configuration status accounting; • Manage configurations of software, engineering documents, design drawings, engineering changes and notices, and planning/conducting design audits with the required skills and experience necessary to work closely with program management, systems engineers, quality managers, and design engineers in an integrated product team environment; • Support requirements and change control boards via meeting attendance and capturing meeting minutes; • Track and manage proposed and approved changes, e.g., Engineering Change Proposals (ECPs), Change Requests (CRs), and Discrepancy Reports (DRs) / Problem Reports (PRs), throughout system development & sustainment lifecycle; • Ensure integrity of the baseline including major releases, minor releases, patches, and software maintenance; • Provide QA checks on system baselines, i.e., Functional, Allocated, Product; • Support Licensing tasks and packaging and delivering of software to users; • Maintain the CM library and software repository; • Manage and control system baselines; • Recommend and document comprehensive configuration management plans for software, hardware, firmware, and peripherals for IT systems; • Evaluate data and preparing plans and briefings in support of software-driven systems; • Evaluate and monitor effectiveness of configuration management plans to identify potential and existing problems and make recommendations for resolution; • Audit and review IT system configurations for compliance to required specifications; • Control the configuration of IT systems; and/or, • Develop and manage access and change control guidelines and procedures to avoid unauthorized access and changes to system configurations. Required Qualifications: The Configuration Manager has the knowledge, experience and recognized ability to be considered highly skilled in their technical/professional field. Possesses the ability to perform tasks independently and oversee the efforts of junior and journeyman contractor personnel within the technical/professional discipline. Demonstrates advanced knowledge of their technical/professional discipline as well as possess a comprehensive understanding and ability to apply associated standards, procedures and practices in their area of expertise (Program Office, Enterprise and Staff Level Support interface). • IT Configuration Management experience within the Department of Defense environment; • Formal training and knowledge of configuration management directives, standards, principles (Plan, Identify, Control, AuditNerify, Status Accounting), and techniques; • Experience performing HW and SW configuration audits; • Experience performing the technical administrative activities necessary to manage CM tools, e.g., Git, Gitlab, Jira, Confluence, Bitbucket, AWSConfig, Azure DevOps Server, Insight, Star Team, for inventory control, version control, data duplication, media labeling; • Experience producing release notes and CM reports; • In-depth understanding of the configuration change control process, the role of the Configuration/Change Control Board, and change control documentation; • Experience performing baseline administrative activities for multiple environments; • Performing written and oral communications; • Experience developing briefings for management • Understanding of all phases of the software development life cycle; • Ability to enter and manage system configuration items in a database; • Ability to provide critical analysis in the realm of problem identification and analysis, interpretation and understanding of links between ideas, research, identification of inconsistencies and errors, relevance confirmation, explanation and presentation, creative and open mindedness, evaluation and problem-solving; • Extensive technical writing experience to provide accurate, concise, and clear document designs, collaboration, presentation, and research skills needed to design productive workplace documents and presentations for a variety of purposes and audiences; and/or, • Assist in developing and administering configuration management plans, maintaining design traceability and integrity, convening and managing change control boards, and preparing for and attending major events such as, but not limited to, TIMs, PDRs, CDRs, PCAs, FCAs, and CCBs. Candidate must be a US Citizen - REQUIRED Candidate must possess and be able to maintain a T1/NACI - REQUIRED Master's or Doctorate Degree in a related field and ten years of experience in the respective technical/professional discipline being performed, five years of which must be in the DoD OR, Bachelor's Degree in a related field and 12 years of experience in the respective technical/professional discipline being performed, five of which must be in the DoD OR, 15 years of directly related experience with proper certifications as described in the PWS labor category performance requirements, eight of which must be in the DoD. Preferred Qualifications: Possessing any of the following certifications would be beneficial, but not required: • Certification in Software Configuration Management - Desired. • Certification in Agile Development - Desired, or • Scrum Master Certification - Desired Schedule: (M-F; 8-5) Work Location: Kettering, OH (Dayton/WPAFB)- Onsite Travel: 0-10% Relocation Assistance Available: No Position Contingent Upon Award of Contract: No Equal Opportunity/Affirmative Action Employer: Crossflow ensures that employment decisions and personnel actions are administered fairly, equitably, and in compliance with the federal, state, and local laws and regulations governing EEO and personnel management. All qualified individuals will receive consideration for employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Why Crossflow? Crossflow Technologies is proud to offer such wonderful benefits and perks to our employees; however, we feel the biggest perk is our company culture . click apply for full job details
CAMRIS
Silver Spring, Maryland
Job Description Job Description Overview: We are seeking a Lead Systems Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects. CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs. Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad. Responsibilities: Lead data integrity tasks including set up of testing workflows, configuring user access controls, integrating peripherals, setting automated schedules, managing alarms and general software administration tasks. Support cross-Functional teams acting as the main bridge between bench scientists, quality assurance (QA), and IT infrastructure teams. Collaborate with process engineers, scientists, operators, maintenance personnel, and vendors to identify opportunities for automation improvements and operational efficiencies. Communicate effectively, efficiently, and persistently with internal and external stakeholders including WRAIR Information Management Division, the PBF director and CAMRIS staff) Configure, maintain, troubleshoot, and optimize automation and control systems, including PLCs, machine to machine interfaces, and process data backups. Lead automation system design, implementation, commissioning, qualification, operation, and lifecycle management activities. Compliance & Validation: Ensuring data integrity, maintaining audit trails, and supporting GxP or regulatory standards (such as ISO/EPA guidelines). Assist WRAIR Information Management Division (IMD) and PBF end users with troubleshooting and upgrading applications supporting resolution of technical snags, data migrations, writing custom scripts or reports (e.g., LabVantage, Crystal Reports OSIsoft Pi), and managing data integrity through system upgrades. Coordinate with lab personnel to map out testing processes, perform market research, develop user requirement specifications (URS), and review associated software design specifications or functional specifications, as necessary. Develop and maintain system documentation including user requirements specifications (URS), functional specifications, control narratives, configuration details, password management, and backup protocols. Participate in commissioning, startup, and qualification activities including factory acceptance testing (FAT), site acceptance testing (SAT), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Establish software training for end users coordinating with operations, quality and quality assurance teams including authoring SOPs, creating training resources, and leading classroom training sessions at PBF. Lead the setup, configuration, and daily support of LabVantage modules at PBF. Ensure systems meet regulatory standards like GxP, 21 CFR Part 11, and data integrity (ALCOA+) principles. Support GMP manufacturing activities through adherence to quality systems, change management processes, deviation investigations, and corrective and preventive actions (CAPA). Design, implement and document the connections between the LIMS and lab equipment, chromatography data systems, and/or middleware. Compliance & Validation: Ensure systems meet regulatory standards like GxP, 21 CFR Part 11, and data integrity (ALCOA+) principles. Support engineering facilities, calibrations oversight, and shutdown execution at PBF as required. All other duties as required by the supervisor, manager, or program leadership. Qualifications: A Bachelor's degree in Engineering, Computer Science, Information Systems, Chemistry, Biology, or a related scientific/technical field. Understanding of GMP manufacturing practices and regulated computerized systems including data integrity and Good Automated Manufacturing Practice (GAMP) and ICH Q9 (Quality Risk Management). 5+ years working within R&D, MSAT or GMP environments supporting enterprise software or laboratory informatics, with firsthand LIMS administration and/or process automation experience. Experience with PLCs, DCS, SCADA, HMI systems, instrumentation, and industrial communication frameworks such as OPC-UA. Strong background in SQL, data analysis, and understanding of lab and clean core (manufacturing) workflows. Demonstrated oral and written communication with the ability to translate complex lab procedures into logical software requirements using flow-charts, presentations, and good engineering documentation. Experience managing subcontracted integration resources. Preferred Qualifications Familiarity with SQL databases, OSIsoft, and slocal application data stores associated with research, quality control, and manufacturing equipment. Data processing skills using R, python, Microsoft Excel, JMP and OSIsoft PI for quality control charting and multifactorial analysis. AKTA Unicorn method programing and configuration experience. Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions. Physical Demands Occasionally conduct sedentary work that primarily involves sitting/standing. Occasionally conduct light work that includes moving objects up to 20 pounds. Rarely conduct medium work that includes moving objects up to 50 pounds. Rarely conduct heavy work that includes moving objects up to 100 pounds. Rarely conduct very heavy work that includes moving objects over 100 pounds. Occasionally push or pull less than 25 pounds. Rarely push or pull 25 - 45 pounds. Rarely push or pull more than 45 pounds. Rarely reach above shoulder level. Constantly use both hands. Occasionally stand or walk for more than 25 minutes. Occasionally bend, reach, or twist repeatedly. Occasionally kneel, squat, or stoop. Rarely crawl or climb. Occasionally have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity. Physical Activities Rarely ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like. Rarely move self in different positions to accomplish tasks in various environments, including tight and confined spaces. Occasionally move about to accomplish tasks or move from one worksite to another. Constantly communicate with others to exchange information. Constantly assess the accuracy, neatness, and thoroughness of the work assigned. Environmental Conditions Occasionally work in low temperatures. Occasionally work in high temperatures. Rarely work in outdoor elements, such as precipitation and wind. Occasionally work in noisy environments. Rarely work in small and/or enclosed spaces. PPE and Chemical Requirements Occasionally wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes. Occasionally wear a lab coat. Rarely wear earplugs/muffs. Occasionally work in a Clean Room Uniform. Occasionally wear a disposable dust/surgical mask. Rarely wear a respirator, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA. Other: Sitting/standing should be managed. Extended screen time is expected. Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law. CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays . click apply for full job details
Job Description Job Description Overview: We are seeking a Lead Systems Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects. CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs. Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad. Responsibilities: Lead data integrity tasks including set up of testing workflows, configuring user access controls, integrating peripherals, setting automated schedules, managing alarms and general software administration tasks. Support cross-Functional teams acting as the main bridge between bench scientists, quality assurance (QA), and IT infrastructure teams. Collaborate with process engineers, scientists, operators, maintenance personnel, and vendors to identify opportunities for automation improvements and operational efficiencies. Communicate effectively, efficiently, and persistently with internal and external stakeholders including WRAIR Information Management Division, the PBF director and CAMRIS staff) Configure, maintain, troubleshoot, and optimize automation and control systems, including PLCs, machine to machine interfaces, and process data backups. Lead automation system design, implementation, commissioning, qualification, operation, and lifecycle management activities. Compliance & Validation: Ensuring data integrity, maintaining audit trails, and supporting GxP or regulatory standards (such as ISO/EPA guidelines). Assist WRAIR Information Management Division (IMD) and PBF end users with troubleshooting and upgrading applications supporting resolution of technical snags, data migrations, writing custom scripts or reports (e.g., LabVantage, Crystal Reports OSIsoft Pi), and managing data integrity through system upgrades. Coordinate with lab personnel to map out testing processes, perform market research, develop user requirement specifications (URS), and review associated software design specifications or functional specifications, as necessary. Develop and maintain system documentation including user requirements specifications (URS), functional specifications, control narratives, configuration details, password management, and backup protocols. Participate in commissioning, startup, and qualification activities including factory acceptance testing (FAT), site acceptance testing (SAT), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Establish software training for end users coordinating with operations, quality and quality assurance teams including authoring SOPs, creating training resources, and leading classroom training sessions at PBF. Lead the setup, configuration, and daily support of LabVantage modules at PBF. Ensure systems meet regulatory standards like GxP, 21 CFR Part 11, and data integrity (ALCOA+) principles. Support GMP manufacturing activities through adherence to quality systems, change management processes, deviation investigations, and corrective and preventive actions (CAPA). Design, implement and document the connections between the LIMS and lab equipment, chromatography data systems, and/or middleware. Compliance & Validation: Ensure systems meet regulatory standards like GxP, 21 CFR Part 11, and data integrity (ALCOA+) principles. Support engineering facilities, calibrations oversight, and shutdown execution at PBF as required. All other duties as required by the supervisor, manager, or program leadership. Qualifications: A Bachelor's degree in Engineering, Computer Science, Information Systems, Chemistry, Biology, or a related scientific/technical field. Understanding of GMP manufacturing practices and regulated computerized systems including data integrity and Good Automated Manufacturing Practice (GAMP) and ICH Q9 (Quality Risk Management). 5+ years working within R&D, MSAT or GMP environments supporting enterprise software or laboratory informatics, with firsthand LIMS administration and/or process automation experience. Experience with PLCs, DCS, SCADA, HMI systems, instrumentation, and industrial communication frameworks such as OPC-UA. Strong background in SQL, data analysis, and understanding of lab and clean core (manufacturing) workflows. Demonstrated oral and written communication with the ability to translate complex lab procedures into logical software requirements using flow-charts, presentations, and good engineering documentation. Experience managing subcontracted integration resources. Preferred Qualifications Familiarity with SQL databases, OSIsoft, and slocal application data stores associated with research, quality control, and manufacturing equipment. Data processing skills using R, python, Microsoft Excel, JMP and OSIsoft PI for quality control charting and multifactorial analysis. AKTA Unicorn method programing and configuration experience. Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions. Physical Demands Occasionally conduct sedentary work that primarily involves sitting/standing. Occasionally conduct light work that includes moving objects up to 20 pounds. Rarely conduct medium work that includes moving objects up to 50 pounds. Rarely conduct heavy work that includes moving objects up to 100 pounds. Rarely conduct very heavy work that includes moving objects over 100 pounds. Occasionally push or pull less than 25 pounds. Rarely push or pull 25 - 45 pounds. Rarely push or pull more than 45 pounds. Rarely reach above shoulder level. Constantly use both hands. Occasionally stand or walk for more than 25 minutes. Occasionally bend, reach, or twist repeatedly. Occasionally kneel, squat, or stoop. Rarely crawl or climb. Occasionally have clear vision (near and/or far), depth perception, peripheral vision, and/or visual acuity. Physical Activities Rarely ascend or descend ladders, stairs, scaffolding, ramps, poles, and the like. Rarely move self in different positions to accomplish tasks in various environments, including tight and confined spaces. Occasionally move about to accomplish tasks or move from one worksite to another. Constantly communicate with others to exchange information. Constantly assess the accuracy, neatness, and thoroughness of the work assigned. Environmental Conditions Occasionally work in low temperatures. Occasionally work in high temperatures. Rarely work in outdoor elements, such as precipitation and wind. Occasionally work in noisy environments. Rarely work in small and/or enclosed spaces. PPE and Chemical Requirements Occasionally wear PPE, including but not limited to gloves, face shields/goggles, safety glasses, and safety shoes. Occasionally wear a lab coat. Rarely wear earplugs/muffs. Occasionally work in a Clean Room Uniform. Occasionally wear a disposable dust/surgical mask. Rarely wear a respirator, such as a disposable respirator mask (N-95), half-face/full-face style, PAPR, SCUBA. Other: Sitting/standing should be managed. Extended screen time is expected. Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law. CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays . click apply for full job details