Senior Process Engineer
4 days ago
My client is currently looking for an experienced Process Engineer with a background in Pharma and knowledge fill finish packaging and solvents media preparation.
Description
- Oversee technical transfer activities by authoring and reviewing essential GMP documentation, including Master Batch Records, change controls, protocols, reports, qualifications, and regulatory submissions.
- Interpret and apply GMP requirements and current regulations, developing standardized procedures in collaboration with Operations, Quality, and External Partners.
- Ensure External Partners maintain inspection readiness for routine audits and inspections related to new product introductions or transfers, coordinating efforts with Operations, Quality, and Regulatory teams.
- Contribute to the development and implementation of best practices and business process strategies through active participation and knowledge sharing.
Requirements
- Must have fill finish manufacturing experience for this role (Minimum 3-5 years)
- Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
- Experience in Fill Finish activities – (Vial / Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.)
- Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
- Hands-on experience with membrane in-gel water cleaning processes
Mid-Senior level
Employment typeContract
Job functionManufacturing and Supply Chain
IndustriesPharmaceutical Manufacturing, Chemical Manufacturing, and Medical Equipment Manufacturing
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