Process Engineer

Overview:

PDP is seeking highly skilled and experienced Process Engineers with experience in biopharma process equipment. The ideal candidates will play a crucial role in ensuring the effective and compliant operation of biopharmaceutical manufacturing systems.

Responsibilities:User Requirement Specification (URS): Generate URS for assigned systems.

Design Reviews: Review and approve Basis of Design (BOD) and detailed design documents such as Process Flow Diagrams (PFDs) and Piping and Instrumentation Diagrams (P&IDs).

Procurement: Ensure procurement packages (bill of materials (BOM), datasheets, cutsheets, etc.) meet client equipment specifications.

HAZOP: Track HAZOP action items and ensure they are incorporated into system design.

Model Reviews: Attend 30%, 60%, and 90% model reviews to ensure systems meet operational, safety, and ergonomic requirements.

Lifecycle Documentation: Review and approve system lifecycle documentation (Functional Specifications (FS), System Design Specifications (SDS), I/O lists, etc.) ensuring they meet client requirements.

Factory Acceptance Test (FAT): Attend FAT of associated equipment and automation software bench FAT as required.

Site Acceptance Testing (SAT) and Commissioning: Supervise and execute SAT and commissioning activities. Generate FAT, SAT, and commissioning protocols for assigned equipment ensuring protocols meet client specifications.

Vendor Documentation Requirements (VDR): Ensure VDR meets client requirements.

Maintenance Management: Build Preventative Maintenance (PM) tasks and spare parts lists on the Regeneron Computerised Maintenance Management System (CMMS).

Ideal Background:Education: Minimum: BS in Engineering or Facility Management, preferably in Chemical, Mechanical, Facility, Industrial, Quality, or Pharmaceutical Engineering.

Languages: English - fluent in speaking and writing.

Experience: Minimum 5 years of experience in Biotech or Pharmaceutical cGMP environments.Broad knowledge of engineering disciplines, commissioning, compliance, qualification, and quality aspects of biopharma or pharmaceutical manufacturing.

• This job description is intended to provide a general overview of the position and does not include every task or responsibility that may be required.