CQV Expert

3 days ago

Dublin, Dublin City, Ireland beBeeCqv Full time €60,000 - €80,000

Job Title: CQV Engineer – Utilities

About the Role

We are seeking a highly skilled CQV Engineer to join our team. The successful candidate will be responsible for delivering end-to-end CQV lifecycle documentation and performing equipment and system commissioning.

Key Responsibilities
  • CQV Lifecycle Documentation: Deliver URS, DQs, FAT/SAT, IQ, OQ, and support PQ where applicable.
  • Equipment Commissioning: Perform verification of installation, utilities integration, control functionality, and safety systems.
  • Qualification Strategies: Conduct impact assessments, risk assessments (e.g. ASTM E2500), and define appropriate qualification strategies.
  • Liaison and Coordination: Liaise with vendors, automation, engineering, and quality functions to coordinate execution and resolve issues.
Required Skills and Qualifications
  • Bachelor's Degree: In Engineering, Life Sciences, or related technical field.
  • Extensive CQV Experience: In a GMP-regulated drug substance or biologics manufacturing environment.
  • Commissioning and Qualification: Hands-on experience with commissioning and qualification of large-scale bioprocess equipment, utility systems, and automation-integrated equipment.
  • CQV Best Practices: Deep understanding of CQV best practices, ISPE Baseline Guides, GAMP 5, and ASTM E2500.
  • Capital Projects: Experience working on capital projects, preferably from construction to handover.
  • Protocol Development: Ability to work independently on protocol development, execution, and resolution management.
Why Join Us?

This is an exciting opportunity to work in a fast-paced environment with cutting-edge technology. You will have the chance to learn new skills and develop your expertise in CQV engineering.

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