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Sr. Validation Engineer, Equipment & Sterilization
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Full-time
- This position is responsible for Equipment and Sterilization Validation processes (i.e. included but not limited to Autoclave, SIP, tunnel, dry heat, and VHP studies), that supports commercial and new R&D drug development activities in support of the client projects involving all delivery systems manufactured in Lakewood, NJ plant.
- This highly technical and highly specialized position is responsible for generating, reviewing and approving protocols, deviations and reports; as well as scheduling activities, providing internal and external customer feedback, and ensuring on-time delivery of milestone activities.
- This position will also interact frequently with regulatory/compliance personnel at Renaissance Lakewood LLC. It will ensure compliance to all FDA and international regulations with regard to equipment qualification and sterilization validation activities.
- Perform validation activities within an aseptic pharmaceutical environment.
- Provide technical support for all start-up activities related to temperature mapping, and sterilization programs.
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