List-style-type:disc; padding-left:20px"> 1. Ensure that all products manufactured at the site comply with global microbiological and sterilization requirements. 2. Maintain a comprehensive understanding of all relevant regulatory requirements for microbiology and sterilization. 3. Supervise and support a team of microbiology technicians, ensuring consistent application of microbiological quality standards across the site. 4. Oversee all sterilization and environmental monitoring requirements, ensuring compliance with regulatory guidelines. 5. Lead dose establishment, dose audits, and dose mapping, while preparing cycle time charts as needed to ensure efficient production processes. 6. Conduct thorough reviews of processed product lots, ensuring they meet quality standards before approving them for release. 7. Act as the microbiological technical expert for the site, troubleshooting and solving complex microbiological issues as they arise. 8. Take on additional responsibilities as required by management to ensure the smooth operation of the site. Required Skills and Qualifications: