Role OverviewThe Tech Transfer Process Engineer will assist a client with their NPI technical transfer work in a sterile aseptic fill finish environment. The project will focus on technical turnover with data surrounding products, authoring process control, transfer plans, and laying out the activities that develop the process and validate the site.
What You Will Do
The contractor will be responsible for risk assessment, hands-on-on-batch samples protocol writing, and collaboration with clients. There will be work with change controls, deviations, and written reports to close out the studies.
Why It Might Be a Fit
The ideal candidate will have 8-10 years of pharmaceutical experience, a CDMO background, and experience with aseptic sterile fill finish. They must be hands-on and willing to work on the manufacturing floor.
Requirements
- 8-10 years within pharmaceutical experience
- CDMO background
- Aseptic sterile, fill finish experience, working on lines
- NPI Technical Transfer experience
- Must be hands on and willing to work on the manufacturing floor
- Client facing, confident and organized, hands on
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