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Lead CQV Validation Engineer
Job in
New Bedford, Bristol County, Massachusetts, 02746, USA
Listed on 2026-07-09
Listing for:
QvalFocus Inc.
Full Time
position Listed on 2026-07-09
Job specializations:
-
Engineering
Pharma Engineer, Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
We are seeking a Lead CQV Engineer / Lead Validation Engineer to lead CQV strategy, equipment qualification, and validation activities for GMP manufacturing projects. This role will provide technical oversight, drive qualification execution, review validation deliverables, manage deviations, and coordinate with Engineering, Quality, Operations, and project teams.
Key Responsibilities- Lead CQV and validation strategy for GMP equipment qualification.
- Oversee IQ/OQ/PQ protocol development, execution, and reporting.
- Review and approve validation documentation, deviations, and QSRs.
- Provide technical leadership to CQV and validation teams.
- Coordinate with cross-functional stakeholders to ensure project success.
- Support project schedules, risks, change controls, and GMP readiness activities.
- Bachelor's degree in Engineering, Life Sciences, or related field.
- 10+ years of CQV/Validation experience in pharmaceutical, biotech, biologics, or cell therapy environments.
- Strong experience with equipment qualification, deviations, protocols, and validation documentation.
- Prior experience as a CQV Lead, Validation Lead, or CQV Project Manager.
- Experience with Val Genesis and biologics manufacturing is preferred.
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