Overview
We are seeking an experienced Commissioning, Qualification & Validation (CQV) Engineer to lead and coordinate CQV project activities for all Black Utility area systems in line with the site project strategy.
You will work across all project functions and collaborate closely with HVAC, Process Engineering, Operations, Operational Engineering, Quality Operations, EHS, Logistics, Lean & Digital teams to develop and execute the optimum commissioning & validation strategy.
Key Responsibilities
Lead and guide CQV activities for black utility systems, ensuring timely execution and compliance with industry regulations
Develop, review, approve, and execute commissioning activities, managing all identified issues in accordance with site/project procedures
Generate, review, and approve Commission Plans, SRA, URS's, IOC's, and Close‑out Reports
Manage and coordinate Black Utility system equipment commissioning activities
Review and approve vendor/field turnover packs for all Black Utility Systems equipment
Act as the CQV point of contact between clients, internal teams, and external vendors to drive project success
Provide technical oversight and guidance to resolve issues collaboratively as they arise
Identify and mitigate project risks while ensuring deliverables meet required quality and compliance standards
Experience
Clear understanding and proven experience in deployment and execution of Risk‑Based Commissioning (RBV) processes in line with ISPE guidelines in a large Capex environment
Experience with digitized C&Q platforms (e.g., Kneat Solutions)
Hands‑on experience with systems such as:
Mains Water
Instrument Air
Cooling Water Generation & Distribution
Chilled Water Generation & Distribution
Vents & Natural Gas
Previous experience as Senior CQV Engineer with a strong technical background
Relevant Degree and/or 10+ years' experience in biotech/pharmaceutical industry‑qualifying GxP systems
Clear understanding of regulatory requirements for EU and other regulatory bodies
Excellent verbal and written communication skills with proven ability to build strong working relationships across departments
Strong analytical problem‑solving skills – a dynamic decision‑maker, effective planner, and communicator
Solution‑driven mindset with the ability to thrive in a fast‑paced, dynamic environment
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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