CQV Engineer (HVAC & Facilities)
Tandem Project Management View all jobs
- Cork
- Contract
- Full-time
- Lead 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.
- 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 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.