Apply
CQV Lead
 |
Location | Netherlands |
 |
Job Type | Contract |
Key Responsibilities Lead start-up and commissioning activities for upstream manufacturing equipment. Oversee FAT, SAT, commissioning, and execution of IQ, OQ and PQ protocols. Drive qualification activities for single-use systems, bioreactors and HVAC. Coordinate activities across Engineering, CQV, Validation, Operations, Quality and vendors. Manage project timelines, priorities and deliverables to meet key milestones. Review and approve…
Responsibilities
Key Responsibilities
- Lead start-up and commissioning activities for upstream manufacturing equipment.
- Oversee FAT, SAT, commissioning, and execution of IQ, OQ and PQ protocols.
- Drive qualification activities for single-use systems, bioreactors and HVAC.
- Coordinate activities across Engineering, CQV, Validation, Operations, Quality and vendors.
- Manage project timelines, priorities and deliverables to meet key milestones.
- Review and approve commissioning and qualification documentation.
- Support issue resolution, deviations and technical troubleshooting during commissioning.
- Ensure all activities are executed in line with GMP requirements and project procedures.
Requirements
- 8+ years’ experience within CQV or Validation in GMP pharmaceutical or biotechnology environments.
- Proven experience leading start-up, commissioning and qualification activities.
- Strong knowledge of FAT, SAT, IQ, OQ and PQ execution.
- Hands-on experience with upstream process equipment, including single-use technologies and bioreactors.
- Experience commissioning and qualifying HVAC systems within GMP facilities.
- Strong project management skills with the ability to manage timelines and multiple stakeholders.
- Previous vendor management and coordination experience.
- Excellent communication skills and the ability to work effectively across cross-functional teams.
Apply
If this position interests you, and you would like to learn more or explore other available jobs that could also match your skill set, please apply today or email spencer@staging.blackfieldassociates.com