CQV Engineer – Utilities & Equipment - Ireland, Dublin - 12 Month Contract
One of the top 10 best companies to work in Ireland is looking for aCQV Engineer – Utilities & Equipment for their large-scale new facility in Dublin. Is this you?
An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
Responsibilities include:
* 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.
Key requirements include:
* 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.
If this role is of interest, please apply now!
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