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.