CQV Lead
Commissioning, qualification and validation firm, major pharma clients
About the role
You will lead commissioning, qualification and validation on new and expanded pharma and biotech facilities, getting equipment, utilities and systems ready for production on schedule.
You will build and lead a small CQV team on client sites, working with owner quality and engineering groups, construction teams and vendors from early planning through the PPQ date.
What you will own
- CQV strategy and plans for facilities, utilities and process equipment
- Leading a team of CQV engineers and specialists on site
- Risk-based commissioning and qualification protocols (IQ/OQ/PQ)
- Coordination with owner quality, engineering and construction teams
- Schedule, deviations and turnover packages
- Client relationship and reporting on qualification progress
What we are looking for
- 8+ years in CQV for pharma, biotech or other GMP facilities
- Led CQV teams, not only executed protocols
- Strong knowledge of risk-based C&Q (ASTM E2500, ISPE Baseline Guides)
- Experience across utilities, HVAC and process equipment
- Comfortable working directly with owner quality teams
- Clear written documentation and reporting
- Open to client-site work in NJ and PA
Nice to have
- Biologics, fill-finish or cell and gene therapy projects
- Computer system validation (CSV) exposure
- Experience at a CQV consultancy or A/E firm
- Open to contract or full-time
What working with Satoriq is like on this search
You will talk with a Satoriq recruiter who works life sciences engineering every day. We share the full picture on the first call, prep you for each interview, and you will hear back within two business days either way.
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