What are the responsibilities and job description for the CQV Lead position at i-Pharm GxP?
CQV Lead – Biologics Manufacturing Expansion
Location: Kankakee, Illinois, USA
Contract / Full-Time
W2 ONLY, competitive rate expenses covered
Overview
We 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 Responsibilities
- Lead all CQV activities across facilities, utilities, and process equipment from design through to handover
- Develop and implement CQV plans, protocols, and schedules aligned with project and site milestones
- Coordinate commissioning and qualification efforts with engineering, operations, quality, and external vendors
- Oversee execution of FATs, SATs, commissioning, and IQ/OQ/PQ activities
- Ensure all validation documentation meets GMP and regulatory requirements
- Drive a risk-based approach to CQV, leveraging industry best practices to optimize delivery
- Manage and mentor CQV engineers and contractors on-site
- Support deviation investigations, change control, and CAPA activities related to CQV scope
- Act as the primary CQV interface for project leadership and quality teams
- Support system turnover, punch-list management, and readiness for GMP operations
Required Experience & Qualifications
- 8–12 years of CQV experience within pharmaceutical, biologics, or biotechnology manufacturing
- Demonstrated experience leading CQV scope on large capital projects or site expansions
- Strong 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 desirable
- Proven ability to manage cross-functional teams and multiple stakeholders
- Strong documentation review and approval experience