CQV Engineer

My client is seeking an experienced CQV (Commissioning, Qualification, and Validation) Engineer to support a high-impact capital project in a drug substance manufacturing environment. This is a contract position for a skilled professional with a proven background in CQV delivery across equipment and utility systems within GMP-regulated facilities.

The successful candidate will contribute to the execution of a fast-paced CQV program, working independently or as part of a cross-functional team to ensure timely and compliant system readiness for GMP operations.

Key Responsibilities:

• Deliver full-cycle CQV documentation including URS, DQ, FAT/SAT, IQ, OQ, and support PQ activities where required

• Commission equipment and systems, verifying installation, utility integration, control functionality, and safety features

• Lead CQV activities across systems such as:

  • Bioreactors and single-use technologies

  • Chromatography columns

  • CIP and SIP systems

  • WFI, clean steam, and process gases

  • Process tanks, skids, and associated piping

• Conduct impact assessments and risk assessments (e.g. ASTM E2500) and define qualification strategies

• Collaborate with vendors, automation, engineering, and quality teams to coordinate execution and resolve issues

• Lead or support resolution of deviations, non-conformances, and change controls

• Maintain GMP-compliant documentation with attention to data integrity

• Provide regular progress updates and support system readiness reviews and handover milestones

Required Experience & Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field

• Minimum 5 years of CQV experience in drug substance or biologics manufacturing under GMP

• Hands-on experience with commissioning and qualification of:

  • Large-scale bioprocess equipment

  • Utility systems (e.g. WFI, HVAC, compressed gases, clean steam)

  • Automation-integrated systems (e.g. DeltaV)

• Strong knowledge of CQV best practices and industry standards (ISPE Baseline Guides, GAMP 5, ASTM E2500)

• Prior involvement in capital projects from construction through handover

• Ability to work independently on protocol generation, execution, and deviation resolution
  
  

  The Next Step for you:

  Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.

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