Sterility Assurance Manager
Thermo Fisher Scientific · Seneffe, Belgium
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Role summary
Thermo Fisher Scientific seeks a Senior QA Sterility Assurance Subject Matter Expert for its Seneffe, Belgium biopharmaceutical site. The role involves leading sterility assurance strategy, contamination control, environmental monitoring, and aseptic manufacturing standards across multi-product clinical and commercial operations.
What they're looking for
- Master's degree in Biology, Biochemistry, Chemistry, or related scientific discipline
- Minimum 10 years of relevant pharmaceutical industry experience
- Expert knowledge of aseptic processing and contamination control strategies
- Experience with environmental monitoring, sterilization, and process simulation
- Understanding of GMP regulations and regulatory compliance requirements
- Leadership and cross-functional collaboration skills
What you'll be doing
- Serve as site sterility assurance lead and subject matter expert with decision-making authority
- Develop and maintain contamination control strategy and aseptic improvement plans
- Review and approve aseptic process simulations and environmental qualification protocols
- Conduct facility inspections, audits, and investigations related to sterility and contamination events
- Represent the site in customer and regulatory audits; lead sterility assurance training across functions
Privacy & handoff
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