We are seeking a Quality Validation Engineer to join our client, a leading Medical Device company based in Cork. This is a 12-month hourly rate contract position supporting ongoing commercial manufacturing and quality systems streamlining.
Key Responsibilities:
- Author, execute, and finalize validation protocols and reports (IQ, OQ, PQ, and CSV) across commercial manufacturing equipment, utilities, and automated systems.
- Manage end-to-end Change Control processes, ensuring process and equipment modifications in commercial production maintain full regulatory compliance without supply disruption.
- Lead investigations into Quality and Validation Deviations utilizing structured Root Cause Analysis (RCA) techniques to determine failure modes.
- Design, own, and implement robust Corrective and Preventive Actions (CAPAs) to drive continuous improvement and mitigate repeat issues.
- Participate in and support Internal Quality Audits to ensure site readiness and continuous alignment with cGMP and global regulatory guidelines.
- Collaborate with cross-functional teams to streamline Quality Systems, optimizing validation workflows to increase efficiency and maintain process capability.
Skill, Attributes & Experience:
- Degree in Engineering or Life Sciences or a closely related technical discipline.
- 5-10 years of hands-on Quality Systems and Validation experience strictly within the Pharmaceutical sector.
- Demonstrated expertise in managing Change Controls, executing CAPAs, and investigating complex manufacturing Deviations.
- Direct experience conducting or participating in Internal Audits within a pharma facility.
- Strong working knowledge of process validation lifecycle concepts, regulatory requirements (FDA/EMA, Annex 15), and quality risk management.
- Excellent communication and root-cause problem solving skills.
