-
Job Description
Process Engineer required for biopharma client in Limerick, Ireland, to work on system lifecycle documentation, user requirement specification, and commissioning activities.
Job Description
PM Group, an employee-owned international project delivery firm, is seeking a Process Engineer to join their team. With a network of offices in Europe, Asia, and the US, they work with leading organisations in the pharma, food, medtech, and mission critical sectors.
Responsibilities
- Reviews and approves system lifecycle documentation, ensuring it meets requirements.
- Generates User Requirement Specification (URS) for assigned systems.
- Reviews and approves Basis of Design (BOD) and detail design of assigned systems, including PFDs and P&IDs.
- Ensures procurement packages meet equipment specifications.
- Attends factory acceptance test (FAT) and automation software bench FAT if required.
- Supervises and executes Site Acceptance Testing (SAT) and commissioning activities.
- Ensures Vendor Document Requirements (VDR) meet requirements.
- Builds Preventative Maintenance (PM) tasks and spare parts lists on Computerised Maintenance Management System (CMMS).
- Generates FAT, SAT, and commissioning protocols for assigned equipment.
Qualifications
- Engineering 3rd level qualification (Chemical, Process Engineering or equivalent).
- Proven expertise in providing personnel to meet project requirements.
- Supply proven Subject Matter Experts (SMEs) for assigned tasks and areas.
- Have sufficient staff available with relevant skills for the project.
- Project and/or operations experience within a process or biopharmaceutical cGMP regulated environment.
- Experience of bioprocessing equipment specification, commissioning, and operation.