Leading Bioprocess Equipment Commissioning Specialist

3 days ago


Dublin, Dublin City, Ireland beBeeCqv Full time €70,000 - €100,000
CQV Engineer Position Overview

Our organization is seeking an experienced CQV engineer to join our team in Dublin. This is a unique opportunity to work on large-scale new facility projects and contribute to the development of cutting-edge bioprocess equipment.

The ideal candidate will possess extensive experience in commissioning and qualification of large-scale bioprocess equipment, utility systems, and automation-integrated equipment. Strong knowledge of CQV best practices, ISPE Baseline Guides, GAMP 5, and ASTM E2500 is also required.

Responsibilities:
  • Deliver end-to-end CQV lifecycle documentation, including 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, 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.
Requirements:
  • Bachelor's degree in Engineering, Life Sciences, or related technical field.
  • Extensive CQV experience in a GMP-regulated drug substance or biologics manufacturing environment.
  • Hands-on experience with commissioning and qualification of large-scale bioprocess equipment, utility systems, and automation-integrated equipment.
  • Deep understanding of CQV best practices, ISPE Baseline Guides, GAMP 5, and ASTM E2500.


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