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CQV Professional

2 weeks ago

Dublin, Dublin City, Ireland beBeeCqv Full time €80,000 - €150,000
Job Overview

We are seeking an experienced CQV Engineer – Utilities to join our team in a role that involves ensuring the quality and safety of large-scale bioprocess equipment and utility systems.

This is a fantastic opportunity for a professional with a strong background in commissioning and qualification of large-scale bioprocess equipment, utility systems, and automation-integrated equipment.

Key Responsibilities:
  • Lifecycle Documentation: Develop and implement comprehensive CQV lifecycle documentation, including URS, DQs, FAT/SAT, IQ, OQ, and support for PQ where applicable.
  • Commissioning and Qualification: Perform equipment and system commissioning, including verification of installation, utilities integration, control functionality, and safety systems.
  • Risk Assessments: Conduct impact assessments, risk assessments, and define appropriate qualification strategies.
  • Team Collaboration: Liaise with vendors, automation, engineering, and quality functions to coordinate execution and resolve issues.
  • Problem-Solving: Support and lead the resolution of deviations, non-conformances, and change controls related to CQV scope.
  • Documentation Management: Maintain up-to-date and compliant documentation in line with GMP and data integrity requirements.
Required Skills and Qualifications:
  • Bachelor's Degree: Bachelor's degree in Engineering, Life Sciences, or related technical field.
  • Extensive Experience: Extensive CQV experience in a GMP-regulated drug substance or biologics manufacturing environment.
  • Hands-on Experience: 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 from construction to handover.

This is a great opportunity to develop your skills and work in a fast-paced environment.