3 Days Left CQV Engineer – Utilities
4 weeks ago
Overview CQV Engineer – Utilities & Equipment - Ireland, Dublin - 12 Month Contract
One of the top 10 best companies to work in Ireland is looking for a CQV Engineer – Utilities & Equipment for their large-scale new facility in Dublin. This exciting project offers lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This client offers the opportunity to work within a large-scale environment with cutting edge technology.
Responsibilities Deliver end-to-end CQV lifecycle documentation: URS, DQs, FAT/SAT, IQ, OQ, and support for PQ where applicable.
Perform equipment and system commissioning, including verification of installation, utilities integration, control functionality, and safety systems.
Conduct impact assessments, risk assessments (e.g. ASTM E2500), and define appropriate qualification strategies.
Liaise with vendors, automation, engineering, and quality functions to coordinate execution and resolve issues.
Support and lead the resolution of deviations, non-conformances, and change controls related to CQV scope.
Maintain up-to-date and compliant documentation in line with GMP and data integrity requirements.
Provide progress updates and contribute to system readiness reviews and handover milestones.
Qualifications Bachelor’s degree in Engineering, Life Sciences, or related technical field.
Requires extensive CQV experience in a GMP-regulated drug substance or biologics manufacturing environment.
Demonstrated hands-on experience with commissioning and qualification of: Large-scale bioprocess equipment, Utility systems (WFI, HVAC, compressed gases, clean steam), Automation-integrated equipment (DeltaV).
Deep understanding of CQV best practices, ISPE Baseline Guides, GAMP 5, and ASTM E2500.
Experience working on capital projects, preferably from construction to handover.
Ability to work independently on protocol development, execution, and resolution management.
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