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