Quality Validation Engineer

Morgan McKinley; Cork; On-site; EUR 55,000 - 83,000; Full time

Job summary

A leading Medical Device company in Cork, Ireland seeks a Quality Validation Engineer for a 12-month contract to support ongoing manufacturing and quality system streamlining.

You will author validation protocols (IQ/OQ/PQ/CSV), manage end-to-end change controls, lead deviation investigations, implement CAPAs, support internal audits, and collaborate across functions to enhance process capability and efficiency.

Qualifications

• 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.

Responsibilities

• Author, execute, and finalize validation protocols and reports (IQ, OQ, PQ, and CSV) across manufacturing equipment, utilities, and automated systems.
• Manage end-to-end Change Control processes, ensuring modifications maintain full regulatory compliance without supply disruption.
• Lead investigations into Quality and Validation Deviations utilizing RCA techniques to determine failure modes.
• Design, own, and implement CAPAs to drive continuous improvement and mitigate repeat issues.
• Participate in and support Internal Quality Audits to ensure site readiness and alignment with cGMP and global regulatory guidelines.
• Collaborate with cross-functional teams to streamline Quality Systems and optimize validation workflows.

Skills

Validation

Quality Systems

CAPA

Change Control

Audits

Root Cause Analysis

Education

Engineering or Life Sciences

Job description

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.

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