Summary
Our client, a pharmaceutical company based in Cork, is seeking a CQV Engineer (Black Utilities) to join their team on a large-scale capital project. The successful candidate will lead and coordinate commissioning, qualification and validation activities for all black utility area systems, working in line with the site project strategy. The role requires close collaboration across multiple functional teams, including HVAC, process engineering, operations, quality, EHS and digital, to develop and execute an optimum commissioning and validation strategy.
Responsibilities
Lead and coordinate CQV activities for black utility systems, ensuring timely execution and compliance with industry regulations.
Develop, review, approve and execute commissioning plans, ensuring all issues identified during execution are managed correctly, efficiently and in accordance with site and project procedures.
Generate, review and approve Commissioning Plans, SRAs, URSs, IOCs and Close Out Reports.
Manage and coordinate black utility system equipment commissioning activities.
Review and approve vendor and field turnover packs for all equipment associated with black utility systems.
Act as the CQV point of contact between internal teams and external vendors to drive project success.
Provide technical oversight and guidance to resolve issues as they arise in a collaborative manner.
Identify and mitigate project risks while ensuring all deliverables meet required quality and compliance standards.
Qualifications & Experience
Relevant degree qualification and/or a minimum of 10 years’ experience in the biotech or pharmaceutical industry qualifying GXP systems.
Proven experience as a senior CQV Engineer with a strong technical background.
Clear understanding and hands‑on experience in the deployment and execution of a Risk Based Commissioning (RBV) process in line with ISPE guidelines within a large Capex environment.
Experience with black utility systems such as Mains Water, Plant Steam & Condensate, Instrument Air, Cooling Water Generation & Distribution, Chilled Water Generation & Distribution, Vents and Natural Gas.
Experience working with a digitised C&Q platform, such as Kneat Solutions.
Strong understanding of regulatory requirements for EU and other regulatory bodies, ensuring CQV is delivered in line with all applicable requirements and guidelines.
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