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 E****) 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 E****)
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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