We are seeking a Lead CQV Engineer / CQV Project Manager to serve as the primary CQV technical lead for project scope. This resource will own CQV execution strategy, deliverable approach, reviewer alignment, documentation quality, deviation strategy, and technical oversight across equipment workstreams.
Lead CQV Engineer Responsibilities:
• Lead CQV strategy and execution planning for GMP equipment qualification scope
• Own documentation strategy for URS revisions, readiness checklists, IOQ/PQ protocols, and QSRs
• Coordinate technical alignment across engineering, CQV, quality, operations, and vendor teams
• Review and guide CQV deliverables for consistency, completeness, and GMP readiness
• Support deviation/discrepancy strategy and execution issue resolution
• Provide technical oversight to CQV leads, senior engineers, and execution resources
• Support prioritization of Phase 1 and Phase 2 deliverables
• Partner with the Senior Project Manager on schedule, risks, issues, and change control
Job Requirements:
• 10+ years direct CQV experience in GMP pharmaceutical, biologics, cell therapy, or life sciences environments
• Prior CQV technical lead, CQV PM, or validation lead experience
• Strong experience with equipment qualification, protocol generation, execution, deviations, and QSRs
• Ability to lead documentation generation and technical review
• Biologics or cell therapy manufacturing experience preferred
• Experience with CQV standards, ValGenesis, or large pharma validation workflows
• Experience supporting fast-paced GMP readiness or capacity expansion projects
This role requires the ability to be on-site, full-time in Devens, MA.
Never miss an opportunity! Create an alert based on the job you applied for.