Commissioning & Qualification Engineer – Dublin

About the role

We are looking for an experienced Commissioning & Qualification (CQ) Engineer to join our Dublin team and support the start‑up of a state‑of‑the‑art bio‑pharmaceutical facility. The role covers both process equipment and utilities, guiding projects from design through to final close‑out.

Key responsibilities

• Lead and execute CQ activities for process equipment and utilities such as purified water, clean steam, HVAC and compressed air.
• Develop, review and approve DQ, IQ, OQ and PQ protocols, summary reports and traceability matrices.
• Support or oversee vendor FATs/SATs and coordinate with system owners, automation and validation teams.
• Embed CQ requirements during design reviews and manage punch‑listing, issue tracking and closure.
• Troubleshoot equipment and system issues in partnership with engineering, automation and maintenance.
• Ensure compliance with cGMP, GEP, safety standards and relevant EU/FDA regulations.
• Assist with project scheduling, resource planning, risk assessments and status reporting.
• Coach and mentor junior team members as needed.

Required profile

• Bachelor’s degree in Engineering (Chemical, Mechanical, Process or related) or equivalent experience.
• Minimum 5 years of CQ experience in life‑sciences, preferably bio‑pharmaceuticals.
• Proven track record across the full qualification lifecycle.
• Broad knowledge of process equipment and utilities systems.
• Strong understanding of cGMP, EU/FDA requirements, ASTM E2500 and ISPE Baseline Guides.
• Excellent organizational, documentation and stakeholder‑management skills.

Required skills

• Commissioning & Qualification
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Factory Acceptance Test (FAT)
• Site Acceptance Test (SAT)
• cGMP compliance
• EU/FDA regulatory knowledge
• ASTM E2500
• ISPE Baseline Guides
• Process equipment qualification
• Water systems (purified water, clean steam)
• HVAC systems
• Compressed air systems

What we offer

• Opportunity to work on a major bio‑pharmaceutical project.
• Dublin‑based site with a dynamic, collaborative team.
• Contract role with potential extension for high performers.