Process Engineer
Our client, a Clinical Stage Gene Therapy company based in Shannon, seeks an experienced Process Engineer to support their manufacturing operations.
Key Responsibilities
Manufacturing Support: Collaborate with the manufacturing team to ensure smooth production processes in a GMP environment. Capital Projects: Participate in the design and review of capital projects 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 development of specifications for single-use equipment items. Provide input to Process Failure Modes and Effects Analysis (FMEA). Engineering Standards: Assist in implementing and developing applicable engineering specifications and standards. Safety, Health, and Environment (SH&E): Contribute to SH&E programs, including risk assessments, safety investigations, and other safety improvement activities. GMP and Documentation Compliance: Ensure all work complies with GMP, Data Integrity, and Good Documentation Practice (GDP). Continuous Improvement: Demonstrate a right-first-time ethos while ensuring compliance with statutory, regulatory, and company standards, procedures, and systems. Waste Reduction and Energy Efficiency: Identify and implement technology-based solutions to reduce waste and overall cost. Requirements
A degree in a related Engineering or Science discipline. A minimum of 5 years' experience in a biopharmaceutical environment in a process engineering role. Essential knowledge of biopharmaceutical process operations, including media and buffer preparation, upstream and downstream processing.