Job Description
Process Project Engineer - Co. Clare Company Information: Our client is a leading Biopharmaceutical company in Co. Clare.The company is committed to delivering innovative and quality productsthat save and improve lives around the world. Known for its industry-leading standards and focus on innovation,offeringa dynamic environment for professional growth and development. This role offers a very competitivesalary and full extensive company benefits package. Role Profile: As a Process Project Engineeryou will be responsible for supporting themanufacturing requirements in a highly regulated GMP environment for the manufacture of Advanced Therapeutic Medicinal Products (ATMPs) whilst working on exciting new projects with the latest state of the art technology. . 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. Safety, Health, and Environment (SH&E): Provide SME input on 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). Complete tasks according to applicable procedures and ensure timely and compliant training. Ensure timely and right-first-time (RFT) closure of GMP documentation, including issues, CAPAs, Change Controls, Batch Manufacturing Records (BMRs), and audit/inspection actions. Continuous Improvement: Demonstrate a right-first-time ethos while ensuring compliance with statutory, regulatory, and company standards, procedures, and systems. Job Competencies: Comprehensive practical and theoretical background in a wide range of biopharmaceutical equipment and manufacturing processes. Familiarity with computerized equipment systems and data integrity principles. Experience with commissioning and qualification of process equipment and utilities. Strong problem-solving skills and the ability to resolve issues in a structured and timely manner. Requirements: Qualified to Degree Level in a related Engineering or Science discipline. Minimum 4-5years experience in a biopharmaceutical environment in a process engineering or similar role. Cleanroom working knowledge. Knowledge of biopharmaceutical process operations, including media and buffer preparation, upstream and downstream processing (e.g., single-use bioreactors, centrifuges, UF/DF, TFF). Proficient in English (verbal and written). Desirable experience of working in a start-up environment. Desirable experience with fill-finish operations. If youre interested in this opportunity and would like to discuss, please contact Gary at or call Skills: Process Development Troubleshooting Validation Design DMAIC LEAN Quality Assurance Benefits: Paid Holidays Parking Share options Pension Bonus Vouchers Permanent Health Insurance