Job Title: Bioprocess Engineer
The Bioprocess Engineer will provide technical process design support for bioprocess systems on new Process Area CAPEX projects.
Key Responsibilities:
* Develop user requirement specifications (URS) for assigned systems.
* Review and approve basis of design (BOD) and detail designs of assigned systems, including PFDs and P&IDs.
* Evaluate procurement packages to ensure they meet equipment specifications.
* Track HAZOP action items and incorporate them into system designs.
* Attend 30%, 60%, and 90% model reviews to ensure systems meet operational, safety, and ergonomic requirements.
* Review and approve system lifecycle documentation, ensuring it meets requirements.
* Participate in factory acceptance tests (FAT) of associated equipment if required.
* Supervise and execute site acceptance testing (SAT) and commissioning activities.
* Generate FAT, SAT, and commissioning protocols for assigned equipment and ensure they meet specifications.
* Verify vendor document requirements (VDR) meet Regeneron standards.
* Develop preventative maintenance tasks and spare parts lists on the Computerised Maintenance Management System (CMMS).
Requirements:
* A Bachelor's degree in Chemical, Process, or Mechanical engineering with 3-5 years of related experience.
* Direct experience with biopharmaceutical process equipment is preferred.
* May substitute relevant experience for education.
* Desirable skills include experience with design and commissioning within the biopharmaceutical sector and familiarity with DeltaV.