An exciting opportunity has arisen for an experienced Commissioning, Qualification & Validation (CQV) Engineer to support a major large‑scale pharmaceutical expansion project in Cork.
The successful candidate will play a key role in delivering HVAC and Facilities CQV activities within a complex GMP‑regulated manufacturing environment.
This position will involve close collaboration with cross‑functional project teams to ensure systems are commissioned and qualified in line with project timelines, regulatory requirements, and site procedures.
This role is ideal for a senior CQV professional with strong HVAC and facilities qualification experience within the pharmaceutical or biotech sector.
Responsibilities
Lead and coordinate CQV activities for HVAC systems and facility qualification in alignment with project timelines and regulatory expectations.
Develop, review, approve, and execute commissioning and qualification documentation, ensuring any issues identified during execution are appropriately managed.
Prepare and review key CQV documentation including Commissioning & Validation Plans, URS, IOC documentation, and Close‑Out Reports.
Manage and coordinate HVAC system equipment and facility qualification activities across project phases.
Review and approve vendor and field turnover packages for HVAC and facility systems.
Act as the primary CQV liaison between internal project teams, stakeholders, and external vendors.
Provide technical oversight and troubleshooting support during commissioning and qualification activities.
Identify and mitigate project risks while ensuring compliance with GMP and regulatory expectations.
Work collaboratively with Operations, Engineering, Quality, EHS, Logistics, Digital/Automation teams, and project microbiology representatives to ensure successful project delivery.
Required
Degree qualification in Engineering, Science, or a related discipline, or equivalent industry experience.
10+ years’ experience in the biotech or pharmaceutical industry qualifying GxP systems.
Proven experience delivering CQV activities within large CAPEX or expansion projects.
Strong understanding of Risk‑Based Commissioning & Qualification (RBC/RBV) methodologies in line with ISPE guidelines.
Hands‑on experience commissioning and qualifying HVAC and facility systems
Experience working with digitised CQV platforms (e.g., Kneat Solutions) is desirable.
Strong knowledge of EU GMP regulatory requirements and validation expectations.
Excellent communication, planning, and stakeholder management skills.
Strong analytical and problem‑solving abilities in fast‑paced project environments.
If you are looking for a new and refreshing role or have any questions about the position, then give me a call, drop me a message, or apply directly below and get ahead of the crowd! I look forward to hearing from you.
For a confidential discussion about this role, or to apply, send your CV to Corey@ssopersonnel.com or call me, Corey Buckley, Recruitment Consultant – Head of Life Sciences – US/Europe, at +353 (87) 283 9994. Please feel free to visit my LinkedIn profile to see my references/recommendations
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