Hybrid CQV Lead Engineer - Validation & GxP Expert
Verista
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Benefits offered by this job
Job summary
Verista seeks a Validation Lead / CQV Lead to drive validation activities for facilities, utilities, and lab systems in GxP environments. You will author IQ/OQ/PQ protocols, manage deviations, and guide teams toward compliant, timely delivery.
The role requires 7+ years in validation/CQV within life sciences, a relevant bachelor’s degree, and strong cGMP/data integrity knowledge. Hybrid work on-site between Wichita, KS and Boston, MA with competitive pay.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related discipline.
- 7+ years of validation/CQV experience in regulated life sciences.
- Hands-on experience with IQ/OQ/PQ protocols, validation scripts and reports.
- Experience leading validation activities across equipment, facilities, utilities, or systems.
- Strong knowledge of cGMP, risk-based validation, and data integrity concepts.
Responsibilities
- Lead validation activities across CQV projects, including planning and execution.
- Author, review, and approve validation deliverables (URS, plans, protocols, reports).
- Coordinate with Engineering, Quality, Operations, and vendors to meet milestones.
- Manage deviations, change controls, punch lists, and issue resolution.
- Ensure compliance with FDA/EMA expectations and GAMP 5/ASTM E2500.
Skills
Education
Tools
Job description
Verista seeks a Validation Lead / CQV Lead to drive validation activities for facilities, utilities, and lab systems in GxP environments. You will author IQ/OQ/PQ protocols, manage deviations, and guide teams toward compliant, timely delivery.
The role requires 7+ years in validation/CQV within life sciences, a relevant bachelor’s degree, and strong cGMP/data integrity knowledge. Hybrid work on-site between Wichita, KS and Boston, MA with competitive pay.
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