Quality Validation Engineer – Pharma (12-Month Contract)

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

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.