Summary:

• Support environmental control in aseptic processing and microbiology testing, ensuring compliance and driving continuous improvement through cross-functional collaboration.

• Key Responsibilities:
• Lead and execute microbiology testing projects, including method validation, transfer, and sanitization studies.
• Perform and oversee bioburden, sterility testing (including Isolator-based testing), and data trend analysis for environmental monitoring.
• Investigate and document excursions, out-of-specification results, and trends, implementing corrective/preventative actions as needed.
• Author and review technical protocols, reports, and laboratory documentation to ensure compliance.
• Train and support laboratory personnel, coordinate with contract labs, and support cross-functional meetings.