Sterility Assurance Manager

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