CQV Lead

On-site – Lebanon, Indiana – 12-Month Contract (Extension Likely) – Full-Time About the Company We are supporting a large-scale pharmaceutical expansion program and are seeking an experienced Commissioning, Qualification & Validation (CQV) Node Lead to take ownership of a major manufacturing node through commissioning and qualification delivery. About the Role This is a senior leadership role where you will serve as the single accountable CQV owner for a defined process area, leading strategy, execution, service provider management, and stakeholder engagement across a complex, highly regulated project environment. You'll play a critical role in driving CQV readiness, managing construction and turnover interfaces, and ensuring systems are delivered safely, compliantly, and on schedule through to operational readiness. Responsibilities Act as the CQV Node Lead and single point of accountability for commissioning and qualification delivery across a designated manufacturing node. Lead and coordinate CQV service providers, ensuring alignment on execution strategy, schedules, priorities, and deliverables. Develop and implement CQV strategies, plans, and schedules to support project and regulatory requirements. Drive execution across the full CQV lifecycle, including documentation preparation, test development, commissioning, qualification, and punch-list closure. Own node-level CQV reporting, progress tracking, metrics, risk identification, and issue escalation. Coordinate Factory Acceptance Testing (FAT) activities with vendors and project stakeholders. Oversee pre-commissioning activities including instrument calibration, utility readiness, automation support, consumable installation, and system preparation. Manage the construction-to-CQV interface, ensuring efficient turnover and system boundary alignment. Lead critical-path reviews, schedule management, and look-ahead planning to maintain project delivery milestones. Own node-level change management activities and represent CQV within broader project governance forums. Partner closely with Construction, Engineering, Automation, Quality, Operations, and Validation teams throughout project execution. Support Operational Readiness activities and lead system handovers to end users. Provide regular updates to program leadership, sponsors, and key stakeholders on progress, risks, resource requirements, and delivery status. Promote and maintain a strong safety culture across all commissioning and qualification activities. Qualifications Bachelor's degree in Engineering, Science, or a related discipline. 10+ years of commissioning, qualification, and validation experience within pharmaceutical, biotechnology, or life sciences environments. Required Skills Proven experience leading CQV delivery on large capital projects and expansion programs. Strong knowledge of commissioning methodologies, qualification practices, and GMP requirements. Demonstrated ability to manage multiple stakeholders, contractors, and service providers in a fast-paced project environment. Experience managing system turnover, operational readiness, and construction interfaces. Strong understanding of project scheduling, risk management, and critical-path planning. Excellent leadership, communication, and problem-solving skills. Ability to operate independently and drive a complex project area with minimal day-to-day oversight. Preferred Skills Experience on mega-project pharmaceutical capital expansions ($100M+). API, peptide, biologics, or bulk pharmaceutical manufacturing experience. Familiarity with electronic qualification platforms such as Kneat. Knowledge of 21 CFR Part 11 and electronic quality systems. Experience supporting operational readiness and startup programs. Master's degree in Engineering, Science, or a related discipline preferred. #J-18808-Ljbffr i-Pharm GxP