Title: Commissioning & Qualification (CQV) Lead – Manufacturing Expansion
Location: IN
Start Date: July 15th
Duration: 12+ Months
Role:
We are seeking an experienced Commissioning & Qualification (CQV) Lead to support a large-scale pharmaceutical manufacturing expansion project within a GMP-regulated environment. This individual will serve as the primary CQV lead for a designated manufacturing, overseeing commissioning, qualification, startup readiness, and CQV execution activities from design through operational handoff.
This is a highly visible leadership role responsible for driving CQV strategy, coordinating service providers, managing schedules, supporting FATs, overseeing qualification execution, and ensuring successful turnover of systems to operations. The CQV Lead will work closely with Engineering, Construction, Automation, Manufacturing, Validation, Quality, and Operational Readiness teams throughout the project lifecycle.
Key Responsibilities:
• Serve as the primary CQV lead and point of contact for assigned manufacturing systems and facilities
• Develop and execute commissioning, qualification, and startup strategies for GMP manufacturing environments
• Manage CQV schedules, project milestones, critical path activities, and readiness metrics
• Coordinate commissioning and qualification activities across Engineering, Construction, Quality, Validation, Automation, and Operations teams
• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), turnover, and startup activities
• Oversee execution of IQ, OQ, PQ, commissioning protocols, and qualification documentation
• Manage service providers, contractors, and CQV resources supporting project execution
• Coordinate pre-commissioning activities including calibration, automation downloads, utility startup, and system readiness
• Review and approve qualification documentation, protocols, test scripts, deviations, and final reports
• Lead change management activities and support project governance reviews
• Support operational readiness initiatives and system handover to end users
• Drive issue resolution, punch-list closure, risk assessments, and continuous improvement initiatives
• Ensure compliance with GMP regulations, validation standards, and project quality requirements
Preferred Background:
• 10+ years of CQV, validation, engineering, or startup experience within pharmaceutical, biotech, or GMP-regulated manufacturing environments
• Strong experience supporting large-scale capital projects and facility expansions
• Extensive knowledge of commissioning, qualification, validation, and startup methodologies
• Experience leading cross-functional teams and managing multiple stakeholders
• Hands-on experience with GMP manufacturing facilities, utilities, process equipment, and automation systems
• Familiarity with electronic validation systems such as Kneat or similar platforms
• Experience supporting API, peptide, biologics, or sterile manufacturing operations preferred
• Strong understanding of regulatory requirements, GMP documentation practices, and 21 CFR Part 11
• Ability to manage schedules, project risks, and contractor performance in a fast-paced project environment
Skills:
• Commissioning, Qualification & Validation (CQV)
• IQ / OQ / PQ Protocol Development & Execution
• GMP Manufacturing Startup & Operational Readiness
• FAT, SAT & System Turnover Management
• Facilities, Utilities & Process Equipment Qualification
• Change Management & Risk Assessment
• Construction, Engineering & CQV Coordination
• Capital Project & Facility Expansion Support
• Validation Documentation & Regulatory Compliance
• Cross-Functional Leadership & Stakeholder Management