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.