CQV Lead

On-site – Lebanon, Indiana – 12-Month Contract (Extension Likely) – Full-Time

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.

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.

• 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.

• 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.

• 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.

• 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.