CQV Lead

CQV Lead – Biologics Manufacturing ExpansionLocation: Kankakee, Illinois, USAContract / Full-TimeW2 ONLY, competitive rate + expenses covered OverviewWe are supporting a major biologics manufacturing site in Kankakee undergoing significant capital investment and modernization. This role requires an experienced CQV Lead to take ownership of commissioning, qualification, and validation activities across a complex GMP environment.You will be responsible for driving CQV strategy and execution across utilities, facilities, and process systems, ensuring systems are delivered safely, compliantly, and in line with aggressive project timelines.Key ResponsibilitiesLead all CQV activities across facilities, utilities, and process equipment from design through to handoverDevelop and implement CQV plans, protocols, and schedules aligned with project and site milestonesCoordinate commissioning and qualification efforts with engineering, operations, quality, and external vendorsOversee execution of FATs, SATs, commissioning, and IQ/OQ/PQ activitiesEnsure all validation documentation meets GMP and regulatory requirementsDrive a risk-based approach to CQV, leveraging industry best practices to optimize deliveryManage and mentor CQV engineers and contractors on-siteSupport deviation investigations, change control, and CAPA activities related to CQV scopeAct as the primary CQV interface for project leadership and quality teamsSupport system turnover, punch-list management, and readiness for GMP operationsRequired Experience & Qualifications8–12+ years of CQV experience within pharmaceutical, biologics, or biotechnology manufacturingDemonstrated experience leading CQV scope on large capital projects or site expansionsStrong technical knowledge of:GMP utilities (WFI, clean steam, HVAC, compressed gases, chilled water, etc.)Process equipment (bioprocessing, purification, or fill-finish preferred)Solid understanding of commissioning practices and validation lifecycle (ASTM E2500, ISPE guidance)Experience working in brownfield or legacy site upgrade environments highly desirableProven ability to manage cross-functional teams and multiple stakeholdersStrong documentation review and approval experience