As Senior Microbiologist, you will be responsible for ensuring sterility compliance of medical devices in accordance with applicable regulatory standards. You will support the validation, monitoring, and continuous improvement of cleaning and sterilization processes, collaborating cross-functionally to ensure product quality and regulatory compliance in a global, regulated environment.
**Main responsabilities:**
+ Oversee and support sterility assurance activities for Finished Goods, including environmental monitoring, bioburden, endotoxin testing, and utilities monitoring (e.g., water, compressed air). + Review and approve microbiology and sterilization documentation for Finished Goods, including validation protocols and reports for cleaning and sterilization processes. + Support validation and monitoring of sterilization processes for Finished Goods, including EtO (ISO 11135) and radiation sterilization (ISO 11137). + Analyze m...