CQV Engineer Role

20 hours ago

Dublin, Dublin City, Ireland beBeecqvengineer Full time €90,000 - €120,000

Job Title: CQV Engineer – Utilities

We are seeking a highly skilled CQV Engineer to join our team in Dublin.

CQV Engineer Job Description

This is an exciting opportunity for a talented professional who wants to deliver end-to-end CQV lifecycle documentation, perform equipment and system commissioning, and conduct impact assessments.

Key Responsibilities:

  • Deliver high-quality CQV lifecycle documentation, including URS, DQs, FAT/SAT, IQ, OQ, and support for PQ where applicable.
  • Perform equipment and system commissioning, ensuring installation verification, utilities integration, control functionality, and safety systems are verified.
  • Conduct thorough impact assessments, risk assessments (e.g. ASTM E2500), and define suitable qualification strategies.
  • Liaise with vendors, automation, engineering, and quality functions to coordinate execution and resolve issues efficiently.
  • Support and lead the resolution of deviations, non-conformances, and change controls related to CQV scope effectively.
  • Maintain up-to-date and compliant documentation in line with GMP and data integrity requirements.
  • Provide regular progress updates and contribute to system readiness reviews and handover milestones.

Requirements

  • Bachelor's degree in Engineering, Life Sciences, or a related technical field is required.
  • Extensive experience in CQV in a GMP-regulated drug substance or biologics manufacturing environment is essential.
  • Demonstrated hands-on experience with commissioning and qualification of large-scale bioprocess equipment, utility systems (WFI, HVAC, compressed gases, clean steam), and automation-integrated equipment (DeltaV).
  • A deep understanding of CQV best practices, ISPE Baseline Guides, GAMP 5, and ASTM E2500 is necessary.
  • Experience working on capital projects from construction to handover is preferred.
  • The ability to work independently on protocol development, execution, and resolution management is required.

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