Process Engineer
On behalf of our Clinical Stage Gene Therapy Client based in Shannon, we are currently sourcing a Process Engineer to join their team.
Major Activities
1. 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).
2. Capital Projects: Support the design and review of capital projects, particularly for single-use biopharmaceutical manufacturing equipment.
3. Vendor Coordination: Coordinate vendor activities for commissioning, qualification, maintenance, calibration, and process improvements.
4. 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).
5. Engineering Standards: Assist in implementing and developing applicable engineering specifications and standards as they relate to local and multi-site Operations.
6. Safety, Health, and Environment (SH&E): Provide SME input on SH&E programs, including risk assessments, safety investigations, and other safety improvement activities.
7. GMP and Documentation Compliance: Ensure all work complies with GMP, Data Integrity, and Good Documentation Practice (GDP).
8. Complete tasks according to applicable procedures and ensure timely and compliant training.
9. Ensure timely and right-first-time (RFT) closure of GMP documentation, including issues, CAPAs, Change Controls, Batch Manufacturing Records (BMRs), and audit/inspection actions.
10. Continuous Improvement: Demonstrate a right-first-time ethos while ensuring compliance with statutory, regulatory, and company standards, procedures, and systems.
11. Waste Reduction and Energy Efficiency: Identify and implement technology-based and work practice solutions to reduce waste and overall cost.
Key Performance Indicators
12. Deliver sustainable improvements measured by KPIs aligned with safety and quality compliance policies.
13. Support project deliverables, ensuring on-time completion and adherence to quality standards.
14. Proactively contribute to the development and effectiveness of the engineering team.
15. Demonstrate experience working in a highly regulated cleanroom environment within the bioprocessing sector.
Key Job Competencies
16. Comprehensive practical and theoretical background in a wide range of biopharmaceutical equipment and manufacturing processes.
17. Familiarity with computerized equipment systems and data integrity principles.
18. Experience with commissioning and qualification of process equipment and utilities.
19. Strong problem-solving skills and the ability to resolve issues in a structured and timely manner.
20. Leadership qualities with the ability to inspire and motivate others.
21. High motivation with the ability to set and achieve challenging goals.
22. Excellent planning and organizing skills with efficient time management.
23. Professional demeanor with the ability to handle pressure and treat others with respect.
24. Innovative thinking and creativity to meet challenges resourcefully.
25. Effective communication skills, both verbal and written, with good presentation abilities.
26. Job Responsibilities
27. Compliance: Ensure conformance to Site Safety & Quality Management Systems requirements
28. Projects delivery: According to approved scope, schedule and cost provisions.
29. Manufacturing Support: Performance within the business unit to achieve SQSCT Goals & Targets.
Job Background
30. Qualified to Degree Level in a related Engineering or Science discipline.
31. Minimum 5 years’ experience in a biopharmaceutical environment in a process engineering role.
32. Essential cleanroom working knowledge.
33. Essential knowledge of biopharmaceutical process operations, including media and buffer preparation, upstream and downstream processing (e.g., single-use bioreactors, centrifuges, UF/DF, TFF).
If you have the above skills & experience, please contact or Telephone:
#LI-CD1