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Process Validation Engineer
Katalyst Healthcares & Life Sciences • New York County, New York, United States
About the Role
Roles & Responsibilities:
- Support process engineering activities including investigations, process improvement initiative, and process transfers for new product introductions.
- This person will play a key role in introducing a new production line onsite, bringing strong media fill experience to develop and implement and implement a comprehensive media fill strategy to support aseptic manufacturing readiness.
- Responsibilities include supporting stability and technical transfers for both new and existing clients, as well as overseeing manufacturing transfer activities to ensure seamless implementation.
- This position will also involve developing and executing validation studies to test and qualify manufacturing processes, ensuring compliance with GMP standards and regulatory expectations.
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