Manager, Sterility Assurance
Bristol Myers Squibb
1 month ago
On-site
Devens, MA
Operations
Responsibilities:
- Oversee and drive continued compliance of the site contamination control program.
- Ensure execution/support of contamination control strategy (aseptic processes; facility design/modification; gowning certification/recertification; environmental monitoring; clean utility systems; EMPQs).
- Ensure sterility assurance activities comply with regulatory requirements (FDA, EMA, USP) and BMS policies.
- Serve as Sterility Assurance SME for projects, continuous improvement, and Quality Risk Management.
- Own/review eQMS documentation (document revisions, change controls, deviations, CAPAs) and act as SME.
- Support EM/CU metrics and data analysis (EM/CU trends, capacity ramp reports).
- Oversee environmental monitoring, clean utility monitoring, aseptic process simulation, aseptic performance qualification, aseptic observer, and aseptic gowning programs.
- Support validations/qualifications (equipment, facility, microbiological methods), Environmental Action Committee governance, and regulatory filings.
- Perform final review of root cause analyses for EM deviations; support inspections and regulatory inquiries; support manufacturing/production triage meetings; participate in global forums.
Qualifications (skills/experience/education):
- Advanced microbiology and aseptic processing knowledge.
- Experience with QC microbiology and EM/CU monitoring (procedures, techniques, lab methods; EM/CU program development).
- Knowledge of facility control systems (HVAC, utilities, DPs, cleaning/disinfection) and US/EU cGMP.
- Apply ICH Q9 quality risk management; proficiency with SOPs, change control, deviations, CAPAs.
- Strong troubleshooting/investigation and communication; team-oriented, works independently cross-functionally.
- STEM bachelor’s preferred; minimum 6 years in cGMP environment (preferably 3+ years in QC microbiology and/or sterility assurance).
- Cell therapy manufacturing knowledge highly desirable.
Benefits (as stated): health coverage; wellbeing support; 401(k) and insurance/disability; paid time off (flexible time off or annual vacation/holidays by location).
On-site/other: occasional on-call, routine gowning in manufacturing cleanroom; occasional travel may be required.
- Oversee and drive continued compliance of the site contamination control program.
- Ensure execution/support of contamination control strategy (aseptic processes; facility design/modification; gowning certification/recertification; environmental monitoring; clean utility systems; EMPQs).
- Ensure sterility assurance activities comply with regulatory requirements (FDA, EMA, USP) and BMS policies.
- Serve as Sterility Assurance SME for projects, continuous improvement, and Quality Risk Management.
- Own/review eQMS documentation (document revisions, change controls, deviations, CAPAs) and act as SME.
- Support EM/CU metrics and data analysis (EM/CU trends, capacity ramp reports).
- Oversee environmental monitoring, clean utility monitoring, aseptic process simulation, aseptic performance qualification, aseptic observer, and aseptic gowning programs.
- Support validations/qualifications (equipment, facility, microbiological methods), Environmental Action Committee governance, and regulatory filings.
- Perform final review of root cause analyses for EM deviations; support inspections and regulatory inquiries; support manufacturing/production triage meetings; participate in global forums.
Qualifications (skills/experience/education):
- Advanced microbiology and aseptic processing knowledge.
- Experience with QC microbiology and EM/CU monitoring (procedures, techniques, lab methods; EM/CU program development).
- Knowledge of facility control systems (HVAC, utilities, DPs, cleaning/disinfection) and US/EU cGMP.
- Apply ICH Q9 quality risk management; proficiency with SOPs, change control, deviations, CAPAs.
- Strong troubleshooting/investigation and communication; team-oriented, works independently cross-functionally.
- STEM bachelor’s preferred; minimum 6 years in cGMP environment (preferably 3+ years in QC microbiology and/or sterility assurance).
- Cell therapy manufacturing knowledge highly desirable.
Benefits (as stated): health coverage; wellbeing support; 401(k) and insurance/disability; paid time off (flexible time off or annual vacation/holidays by location).
On-site/other: occasional on-call, routine gowning in manufacturing cleanroom; occasional travel may be required.