Lead CQV Engineer

Qualifications

• Bachelor's Degree or equivalent; STEM, Biomedical Engineering, or Chemical Engineering preferred.
• 8+ years of CQV/validation experience in pharma or biotech.
• Strong hands-on execution with process equipment (bioreactors, filtration, chromatography, UF).
• Proven experience in leading validation teams or shift-based execution efforts.
• Strong GMP/GDP knowledge.
• Experience with eVal (required); ValGenesis is a plus.
• Familiarity with temperature mapping (Ellab experience is a plus).

Responsibilities

• Lead second shift CQV execution activities across multiple systems and workstreams.
• Coordinate daily execution priorities to recover schedule delays and maintain timelines.
• Interface with QA, Engineering, and Operations to swiftly resolve issues.
• Oversee execution of IQ/OQ protocols and operational verification activities.
• Support and review drawing walkdowns, equipment and component verification, and Materials of Construction (MOC) and weld verifications.
• Provide oversight for temperature mapping and validation activities.
• Drive the identification, escalation, and resolution of deviations.

Benefits

• Opportunity to work in a dynamic, fast-paced environment.
• Engagement with cross-functional teams to enhance operational efficiencies.
• Career growth potential within a leading pharma/biotech organization.
• Exposure to cutting-edge equipment and technologies.
• Chance to make a significant impact on quality assurance and compliance standards.