Senior Program C&Q Lead
Eli Lilly and Company
Summary
The Senior Program C&Q Lead owns commissioning and qualification (C&Q) for an assigned capital program or site – setting the C&Q strategy, driving field execution, and delivering systems that are validated, GMP-compliant, and ready for reliable startup and handover to Site Operations. This is a senior individual contributor role: the Senior Program C&Q Lead is Lilly's technical owner and single point of accountability for C&Q on the program.
Job description
C&Q Strategy, Planning & Scheduling
- Create, own, and implement the C&Q strategy, plans, and schedules for the assigned program, aligned to Lilly's CQV standards and to the relevant manufacturing platform and network requirements (API, LAPI, PDN, LMF).
- Define system boundaries, system classification, and the commissioning and qualification scope and turnover package structure so testing is executed once, at the right level of rigor, with no gaps or duplication.
- Build and maintain the integrated C&Q schedule, including critical path analysis, 2–4 week look-aheads, and resource loading; integrate C&Q sequencing with construction, automation, and startup milestones.
- Forecast C&Q resource demand and partner with program leadership and service providers to secure the right contingent and contract resources at the right time.
C&Q Execution & Field Coordination
- Direct day-to-day C&Q execution in the field through C&Q firms and contingent C&Q node leads; ensure adherence to C&Q procedures and program strategy in all activities.
- Review and accept mechanical completion (MC) turnover from construction management and C&Q firms, and drive closeout of punch list items with C&Q firms and SWAT teams.
- Coordinate pre-commissioning activities including utility priming, instrument calibration, automation downloads, installation of consumables (e.g., filter cartridges), and VFD setup.
- Coordinate across nodes and with site utilities on demand for temporary power and utilities (e.g., steam, water) and on wastewater discharge and loading of drains and sumps.
- Partner with the mechanical and construction teams on lock-out/tag-out (LOTO) and the transition of systems from construction control to commissioning control.
Factory Acceptance Testing (FAT)
- Plan and lead FAT for the program – defining test strategy, reviewing and approving protocols, setting schedules, and coordinating with vendors, engineering, and construction so equipment and systems are verified ahead of shipment and startup.
- Witness FAT at vendor sites, disposition findings and deviations, and confirm resolution before release to site.
Qualification, Documentation & Handover
- Author, review, and approve commissioning and qualification protocols, test scripts, deviations, and summary reports; ensure right-first-time execution and audit-ready records.
- Ensure structured capture and turnover of engineering and asset information through Project Information Management (PIM) – specifications, drawings, test records, as-builts, and handover data packages – so assets transition to Operations complete and audit-ready.
- Lead or support system handover to the User team and Site Operations, including punch resolution, training support, and documentation turnover.
Quality, Compliance & Safety
- Ensure C&Q activities meet regulatory, corporate, and site quality requirements; partner with Quality and support inspection readiness for the program.
- Manage C&Q change and deviation processes, including impact assessment against the approved scope and escalation of compliance risk.
- Enforce a strong safety culture by ensuring all commissioning and qualification activities comply with site safety standards and industry best practices, promoting a safe working environment for all team members.
Technical Expertise & Continuous Improvement
- Serve as the program's C&Q subject matter expert, providing technical direction and coaching to contract and contingent C&Q resources without a direct reporting relationship.
- Continuously identify opportunities to improve C&Q practices across the program, driving efficiency while maintaining compliance.
- Feed lessons learned back into GFD CQV standards, methods, and templates so improvements are captured for future programs.
Reporting & Governance
- Report progress, risks, and issues directly to program leadership and the Senior Director, Asset Delivery, providing clear visibility into C&Q status, quality, and compliance risk.
- Report program C&Q metrics including change management against initial scope, progress and performance measurement, 2–4 week look-aheads, critical path analysis, and resourcing.
General
Collaborate across detailed design, project engineering, construction, automation, Quality, Site Operations, and program teams; take on priorities as they emerge.
Requirements
- Bachelor's in Engineering, Life Sciences, or a related field
- 15+ years of commissioning, qualification, and validation (CQV) experience in GMP-regulated environments, including leading C&Q execution on capital projects
- Demonstrated hands-on experience across the validation lifecycle – commissioning, qualification, systems turnover, startup support, and handover to operations
- Experience planning and executing Factory Acceptance Testing (FAT) with equipment vendors
- Ability to travel, both within and outside the US as required, approximately 35% expected
- Qualified applicants must be authorized to work in the United States on a full-time basis
- Lilly will not provide support for or sponsor work authorization or visas for this role
Benefits
- 401(k) Matching
- Pension
- Vacation Benefits
- Medical, Dental & Vision
- Prescription Drug Benefits
- Flexible Spending Accounts
- Life Insurance
- Death Benefits
- Employee Assistance Program
- Fitness Benefits
- Employee Clubs & Activities
- Company Bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.