Sterility Assurance Manager
Thermo Fisher Scientific
Thermo Fisher Scientific seeks a Sterility Assurance Manager to oversee sterility assurance systems and programs across a pharmaceutical manufacturing site in Greenville, North Carolina. The role requires expertise in contamination control, environmental monitoring, media fill protocols, and aseptic processing within a regulated GMP environment.
Responsibilities
- Define, own, and maintain contamination control strategy for assigned operational areas
- Oversee environmental monitoring and media fill programs; lead aseptic training and compliance
- Conduct sophisticated investigations into sterility assurance issues and deviations
- Act as subject matter expert in regulatory audits and new product introduction projects
- Represent site on sterile working group; audit other sites and suppliers for compliance
Requirements
- Bachelor of Science in Microbiology, Applied Biology, or related field
- 7+ years of microbiology experience, preferably in pharmaceutical sterile manufacturing
- 5+ years of leadership experience
- Demonstrated knowledge of aseptic processing and media fill simulations
- Familiarity with FDA, EU Annex-1, and pharmaceutical regulations
- Strong root cause analysis and investigative skills
- Excellent technical writing and interpersonal communication abilities
Vacancy posted a month ago
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