​Job Title: Process Engineer

Type: Permanent

Location: Limerick, Ireland

Life Science People has partnered up with a growing Biopharmaceutical facility in Limerick, who are looking for a Process Engineer to help support GMP Process Manufacturing processes.

Key Responsibilities

• Manufacturing Support: Integration into the relevant business unit that supports manufacturing requirements in a highly regulated GMP environment for the manufacture of Advanced Therapeutic Medicinal Products (ATMPs).

• Capital Projects: Support the design and review of capital projects, particularly for single-use biopharmaceutical manufacturing equipment.

• Vendor Coordination: Coordinate vendor activities for commissioning, qualification, maintenance, calibration, and process improvements.

• Technical Transfer: Support technical transfer activities, including design and developing specifications for single-use equipment items. Provide SME input to Process Failure Modes and Effects Analysis (FMEA).

• Engineering Standards: Assist in implementing and developing applicable engineering specifications and standards as they relate to local and multi-site Operations.

• Ensure all work complies with GMP, Data Integrity, and Good Documentation Practice (GDP).

• Ensure timely and right-first-time (RFT) closure of GMP documentation, including issues, CAPAs, Change Controls, Batch Manufacturing Records (BMRs), and audit/inspection actions.

Education & Experience:

• Qualified to Degree Level in a related Engineering or Science discipline.

• Minimum 5 years’ experience in a biopharmaceutical environment in a process engineering role.

• Essential cleanroom working knowledge.