CQV Engineer

Dublin
Contract
Full-time

30 days ago

Are you a highly skilled and experienced CQV Engineer with a proven track record in drug substance manufacturing? We are seeking a dedicated professional to join our fast-paced team on a contract basis, playing a critical role in the commissioning and qualification of equipment and utilities for a bioprocess manufacturing environment.About the RoleAs a CQV Engineer, you will be instrumental in delivering an end-to-end CQV program, ensuring all activities are executed in line with GMP, project timelines, and regulatory expectations. You will work independently or as part of a cross-functional team, taking ownership of qualification protocols, managing deviations, and supporting system handover to GMP operations.Key Responsibilities

Deliver end-to-end CQV lifecycle documentation, including URS, DQs, FAT/SAT, IQ, OQ, and supporting PQ activities.
Perform equipment and system commissioning, including verification of installation, utilities integration, and control functionality.
Lead CQV efforts on critical systems, including:

Bioreactors and single-use technologies
Chromatography Columns
Clean-in-place (CIP) and steam-in-place (SIP) systems
WFI, clean steam, and process gases
Process tanks, skids, and associated piping
Conduct impact assessments, risk assessments (e.g., ASTM E2500), and define appropriate qualification strategies.
Liaise with vendors, automation, engineering, and quality functions to coordinate execution and resolve issues.
Lead the resolution of deviations, non-conformances, and change controls related to CQV scope.
Maintain up-to-date and compliant documentation in line with GMP and data integrity requirements.
Provide progress updates and contribute to system readiness reviews and handover milestones.

Required Experience & Qualifications

Bachelor's degree in Engineering, Life Sciences, or a related technical field.
Minimum 5 years' CQV experience in a GMP-regulated drug substance or biologics manufacturing environment.
Demonstrated hands-on experience with commissioning and qualification of large-scale bioprocess equipment, utility systems (WFI, HVAC, compressed gases, clean steam), and automation-integrated equipment (DeltaV).
Deep understanding of CQV best practices, ISPE Baseline Guides, GAMP 5, and ASTM E2500.
Experience working on capital projects, preferably from construction to handover.
Proven ability to work independently on protocol development, execution, and issue resolution.

If you are a results-driven CQV professional seeking a challenging contract role in a fast-paced biopharmaceutical environment, we encourage you to apply!

Morgan McKinley

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