SummaryOur client, a pharmaceutical company based in East Cork, is seeking a CQV Engineer (HVAC & Facilities) to join their team on a large-scale capital expansion project. The successful candidate will lead and coordinate commissioning, qualification and validation activities for all HVAC systems and facility qualification, working in line with the site project strategy. The role requires close collaboration across utilities, process engineering, operations, quality, EHS, digital and microbiology functions to develop and execute an optimum commissioning and validation strategy.ResponsibilitiesLead and coordinate CQV activities for HVAC systems and facility qualification, ensuring timely execution and compliance with industry regulations.Develop, review, approve and execute commissioning and qualification plans, ensuring all issues identified during execution are managed correctly, efficiently and in accordance with site and project procedures.Generate, review and approve Commissioning and Validation Plans, URSs, IOCs and Close Out Reports.Manage and coordinate HVAC system equipment and facility qualification commissioning and qualification activities.Review and approve vendor and field turnover packs for all equipment associated with HVAC and facility 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 & ExperienceRelevant 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 HVAC and facility systems including AHUs, chilled water, heating hot water, clean rooms, corridors, Personnel Air Locks (PALs) and Material Air Locks (MALs).Experience working with a digitised C&Q platform such as Kneat Solutions is desirable but not essential.Strong understanding of regulatory requirements for EU and other regulatory bodies, ensuring CQV is delivered in line with all applicable requirements and guidelines.Excellent verbal and written communication skills with the ability to build strong working relationships across multiple departments and stakeholder groups.
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