Job Description
Designing and optimizing batch configurations to ensure process reproducibility and effective penetration of the sterilizing agent.
Conducting CQV validation and qualification processes in full compliance with applicable standards and international regulatory requirements.
Monitoring the operation of clean media systems, including clean steam, water for injection, and utility gases such as nitrogen and compressed air.
Analyzing process deviations and performing engineering troubleshooting, including investigating the causes of moist batches after a cycle or positive biological indicator results.
Required Skills and Experience
- In-depth and practical knowledge of various sterilization and depyrogenation methods (in particular: thermal, gas, chemical, and radiation sterilization, as well as sterilizing filtration).
- Experience working with advanced process equipment, especially autoclaves and isolators.
- Solid knowled...