Manager, Contamination Events & Sterility Assurance Support

Bristol Myers Squibb · New Brunswick, NJ +6 more

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QualityFull-time$117k–$141kCompany career page

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Role summary

Bristol Myers Squibb seeks a Manager for Contamination Events & Sterility Assurance Support to oversee microbiological investigations, impact assessments, and contamination control across internal and external manufacturing sites. The role combines technical microbiology expertise with regulatory compliance and cross-functional collaboration to ensure product safety and sterility.

What they're looking for

Bachelor's degree in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or related discipline
Minimum 3 years pharma/biotech GMP microbiology, sterility assurance, or aseptic manufacturing experience
Knowledge of aseptic processing, environmental monitoring, and sterility testing standards (USP chapters, FDA 21 CFR 210/211)
Experience with impact assessments, deviation documentation, and CAPA processes in regulated environments
Familiarity with EU GMP Annex 1, ICH Q9 risk principles, and contamination control strategy concepts
Proficiency with quality management systems (TrackWise, Veeva Vault) and strong data integrity practices
Excellent technical writing and cross-functional communication abilities

What you'll be doing

Support microbiological impact assessments for internal site investigations including EM excursions, bioburden failures, and aseptic deviations
Review and assess sterility/microbiological investigation submissions from external manufacturing partners, escalating risks appropriately
Contribute to contamination control strategy development and aseptic process change control reviews aligned with current GMP guidance
Monitor and trend microbiological data to identify contamination signals; support regulatory inspections and audit preparation
Develop and maintain technical SOPs, guidance documents, and training materials; stay current with evolving regulatory requirements

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