3 Days Left: CQV Engineer

2 weeks ago

Dublin, Ireland Morgan McKinley Full time

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 Role

As 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

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