We are seeking a contract CQV Engineer with proven experience in commissioning and qualification of equipment and utilities in a drug substance (DS) manufacturing environment. The successful contractor will play a critical role in delivering a fast-paced CQV program in line with GMP, project timelines, and regulatory expectations.
You'll be expected to work independently or as part of a cross-functional CQV team to author and execute qualification protocols, manage deviations, and support system handover for GMP operations.
Key Responsibilities:
* Deliver end-to-end CQV lifecycle documentation: URS, DQs, FAT/SAT, IQ, OQ, and support for PQ where applicable.
* Perform equipment and system commissioning, including verification of installation, utilities integration, control functionality, and safety systems.
* Lead CQV efforts on systems including (but not limited to):
- 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.
* Support and 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 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)
- 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.
* Ability to work independently on protocol development, execution, and resolution management.
