15h Left: CQV Engineer – Utilities

4 weeks ago

Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time
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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