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Manager, Contamination Events – Sterility Assurance Support
Bristol Myers Squibb. Support microbiological and aseptic process impact assessments for internal manufacturing investigations, including environmental monitoring excursions, bioburden failures, sterility test failures, and aseptic process deviations .
Posted 9/17/2026full-timeNew Brunswick • New Jersey • United StatesJunior💰 $109,050 - $145,354 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in microbiological processes, aseptic manufacturing, and quality assurance within GMP-regulated environments. Proficient in conducting impact assessments, deviation documentation, and regulatory compliance while collaborating effectively across functions.
Highest-signal resume keywords
Microbiology ExpertiseAseptic ManufacturingGMP DocumentationEnvironmental MonitoringQuality Risk Assessment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
MicrobiologyAseptic Processing PrinciplesSterility TestingDeviation DocumentationCAPA ManagementEnvironmental Monitoring Data TrendingContamination Control StrategyQuality Management SystemsRisk Management PrinciplesTechnical Writing
Soft Skills
Attention to DetailData Integrity AwarenessCommunication Skills
Tools & Technologies
TrackWiseVeeva Vault
Industry Keywords
GMP-Regulated EnvironmentFDA 21 CFR Parts 210/211EU GMP Annex 1ICH Q9Biopharmaceutical
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Support microbiological and aseptic process impact assessments for internal manufacturing investigations, including environmental monitoring excursions, bioburden failures, sterility test failures, and aseptic process deviations
- Evaluate root cause analyses and contribute to product, process, and patient impact assessments under senior scientist guidance
- Author and contribute to impact assessment documentation, deviation records, and CAPA reviews
- Track action items and CAPA effectiveness with site Investigation Leads
- Monitor and trend microbiological data to identify contamination signals and systemic issues
- Collaborate with Microbiology, Quality, MS&T, Manufacturing, and Validation teams
- Prepare documentation and provide technical input for regulatory inspections and internal audits
- Review and assess sterility and microbiological investigation impact assessments from external manufacturing partners
- Provide technical input on external manufacturing assessment quality and root cause adequacy, escalating risks and gaps
- Support quality risk assessments and periodic risk reviews at CMOs/CDMOs
- Participate in remote or on-site technical interactions with external manufacturing partners
- Support environmental monitoring program reviews, cleanroom classification, and gowning qualification
- Contribute to contamination control strategy development and maintenance aligned with EU GMP Annex 1 and ICH Q9
- Support aseptic process change control reviews and cGMP improvements
- Develop and maintain SOPs, guidance documents, and training materials
- Stay current with regulatory guidance and share learnings
- Participate in cross-functional projects, working groups, and sterility assurance and microbiology forums
- Develop technical expertise in aseptic manufacturing, contamination control, and investigation methodology
Requirements
What you’ll need- Required B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline
- Minimum 3 years of experience with a B.S. or 1 year with an M.S. in microbiology, sterility assurance, quality, or aseptic manufacturing within a GMP-regulated pharmaceutical or biopharmaceutical environment
- Foundational knowledge of aseptic processing principles, environmental monitoring programs, and sterility testing
- Experience contributing to GMP impact assessments and deviation/CAPA documentation in a regulated manufacturing environment
- Familiarity with FDA 21 CFR Parts 210/211, EU GMP Annex 1, and USP microbiological chapters
- Strong attention to detail, data integrity awareness, and technical writing ability for GMP documentation
- Experience with environmental monitoring data trending and excursion investigation
- Exposure to aseptic process simulations (media fills) and associated investigations
- Familiarity with contamination control strategy concepts and EU GMP Annex 1 (2022 revision)
- Experience supporting quality risk assessments at External Manufacturing partners from a microbiology or quality perspective
- Proficiency with quality management systems such as TrackWise and Veeva Vault for deviation and CAPA management
- Knowledge of ICH Q9 risk management principles as applied to sterile manufacturing environments
- Ability to work across functions and communicate with technical and quality stakeholders
- Up to 25% travel required
- M.S. in a related scientific discipline preferred
Benefits
Comp & perks- Wellbeing support
- Retirement and financial protection benefits
- Medical, dental, vision, life, and disability insurance offerings
- Flexible Time Off (FTO) for eligible U.S.-based exempt employees
- 11 paid company holidays annually
- 160 hours of paid vacation annually for eligible new hires
- 3 optional holidays for eligible non-exempt, RayzeBio, and Puerto Rico employees
- Paid sick leave, depending on eligibility
- Up to two paid volunteer days per year
- Summer hours flexibility
- Medical, personal, parental, caregiver, bereavement, and military leaves of absence
- Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees
- Additional discretionary incentive cash and stock opportunities