Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA
$110k - $125kDanaher Corporation Office Usa
Senior Manager position leading contamination control and sterility assurance programs across multiple Cytiva manufacturing sites. Provides strategic direction and technical expertise in microbial control, sterilization, and aseptic processing to ensure regulatory compliance and operational excellence.
Responsibilities
- Lead contamination control and sterility assurance programs across multiple manufacturing sites aligned with quality standards and regulatory requirements
- Drive implementation and continuous improvement of contamination control strategies, microbial control programs, and environmental monitoring practices
- Serve as technical subject matter expert for contamination control, sterilization, environmental monitoring, and aseptic processing
- Lead investigations, root cause analysis, and CAPA activities related to contamination events and sterility assurance issues
- Establish and monitor contamination control metrics, trend analysis, and deployment of best practices across manufacturing network
Requirements
- Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, Engineering, or related scientific discipline
- 10+ years experience in pharmaceutical, biotechnology, medical device, or regulated life sciences manufacturing
- Demonstrated expertise in contamination control, sterility assurance, aseptic processing, and environmental monitoring
- Experience supporting regulatory inspections, customer audits, investigations, and CAPA programs
- Experience leading technical teams and cross-functional projects in global, multi-site environments
- Strong knowledge of quality systems, contamination control principles, and regulatory compliance requirements
Compensation: $110,000-$125,000 base
Vacancy posted 21 days ago
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