We're working with a growing CDMO (Contract Development and Manufacturing Organization) to find a hands‑on CQV Manager to lead Commissioning, Qualification, and Validation (CQV) activities across their manufacturing operations.
About the Role
This is a genuinely execution-focused role - you won't just be overseeing from a distance, you'll be directly driving CQV and CSV deliverables on the ground. For the right candidate, there's a clear path to grow into a CAPEX Project Manager role as the site's capital project pipeline expands.
Responsibilities
- Lead and execute Commissioning, Qualification, and Validation (CQV) activities across equipment, systems, and facilities
- Drive Computer System Validation (CSV) processes in line with GxP and regulatory requirements
- Develop and manage validation protocols, master plans, and reports (IQ/OQ/PQ)
- Partner cross-functionally with Engineering, Quality, and Manufacturing teams to ensure validation timelines align with client project milestones
- Support audit and inspection readiness through robust documentation and compliance practices, including client and regulatory audits
- Identify and troubleshoot validation issues, driving resolution in a fast‑paced, hands‑on capacity
- Build toward future ownership of CAPEX project management as site capital projects scale
Qualifications
- Proven experience in CQV and CSV within a CDMO, pharmaceutical, biotech, or GMP‑regulated manufacturing environment
Required Skills
- Hands‑on operational mindset — comfortable executing, not just managing from a distance
- Strong working knowledge of GxP, FDA, and relevant regulatory validation requirements
- Experience with IQ/OQ/PQ protocol development and execution
- Comfortable working across multiple client programs and adapting to varied validation requirements
- Interest in progressing toward CAPEX/capital project management
- Excellent cross‑functional communication and stakeholder management skills
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