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Job Description
Process Engineer (Biotech) required for a leading client in Limerick, with expertise in Biopharma Process equipment and experience in a GMP regulated environment.
PM Group is an employee-owned, international project delivery firm with a team of 3,700+ people, working with the world's 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, as 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, ensuring protocols meet specifications.
Qualifications
- Engineering 3rd level qualification (Chemical, Process Engineering or equivalent).
- Proven expertise in the provision of personnel to meet the requirements.
- Experience of bioprocessing equipment specification, commissioning, and operation.
- Project and/or operations experience within a process or biopharmaceutical GMP regulated environment.