Senior Program C&Q Lead

Lilly • Huntsville, AL

17h • $163,500 - $239,800

About The Position

The Senior Program C&Q Lead owns commissioning and qualification (C&Q) for an assigned capital program or site. This senior individual contributor is Lilly’s technical owner and single point of accountability for program C&Q, setting strategy, driving field execution, and delivering systems that are validated, GMP-compliant, ready for reliable startup, and prepared for handover to Site Operations.

The role works across project management, engineering, construction, automation, Quality, Site Operations, program teams, C&Q firms, contractors, contingent resources, and vendors. It requires travel within and outside the United States as needed, approximately 35% expected; site-based assignments may require extended field deployment.

The position is part of Lilly’s Global Facilities Delivery Organization, which delivers new and renovated capital assets. The anticipated wage is $163,500–$239,800. Full-time equivalent employees are eligible for a company bonus, depending in part on company and individual performance, and may participate in a comprehensive benefits program.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 15 or more years of commissioning, qualification, and validation (CQV) experience in GMP-regulated environments, including leading C&Q execution on capital projects.
• Hands-on experience across the validation lifecycle, including commissioning, qualification, systems turnover, startup support, and handover to operations.
• Experience planning and executing Factory Acceptance Testing (FAT) with equipment vendors.
• Ability to travel within and outside the United States as required; approximately 35% travel is expected, and site-based program assignments may require extended field deployment.
• Must be authorized to work in the United States on a full-time basis; Lilly will not sponsor or support work authorization or visas for this role.

Nice To Haves

• Experience directing C&Q contractors and service providers and coordinating field execution alongside construction teams in an active construction environment.
• Ability to influence and deliver results without direct authority in a complex, matrixed, contractor-leveraged organization.
• Experience delivering C&Q on greenfield and/or GMP-regulated pharmaceutical or life-sciences facilities.
• Experience on mega capital expansion projects with total installed cost of $100 million or more.
• CQV experience in API, LAPI, sterile/parenteral, and/or biologics facilities.
• Master’s degree in engineering, science, or a related field.
• Professional credentials such as ISPE CPIP, PE, or PMP.
• Familiarity with validation or commissioning platforms such as Kneat, Oracle Unifier, Smartsheet, and Power BI.

Responsibilities

• Create, own, and implement C&Q strategy, plans, and schedules aligned with Lilly CQV standards and relevant manufacturing platform and network requirements.
• Define system boundaries, classifications, C&Q scope, and turnover package structure to ensure testing is appropriately rigorous and avoids gaps or duplication.
• Build and maintain the integrated C&Q schedule, including critical path analysis, 2–4 week look-aheads, resource loading, and integration with construction, automation, and startup milestones.
• Forecast C&Q resource demand and work with program leadership and service providers to secure contingent and contract resources.
• Direct day-to-day field C&Q execution through C&Q firms and contingent C&Q node leads, ensuring adherence to procedures and program strategy.
• Review and accept mechanical completion turnover and drive punch-list closeout with C&Q firms and SWAT teams.
• Coordinate pre-commissioning activities, including utility priming, instrument calibration, automation downloads, consumables installation, and VFD setup.
• Coordinate temporary power and utilities, wastewater discharge, and drain and sump loading across nodes and with site utilities.
• Partner with mechanical and construction teams on lock-out/tag-out and transfer of systems from construction control to commissioning control.
• Plan and lead Factory Acceptance Testing (FAT), including defining test strategy, reviewing and approving protocols, setting schedules, and coordinating vendors, engineering, and construction.
• Witness vendor-site FAT, disposition findings and deviations, and confirm resolution before equipment release to site.
• 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), including specifications, drawings, test records, as-builts, and handover packages.
• Lead or support system handover to User teams and Site Operations, including punch resolution, training support, and documentation turnover.
• Ensure C&Q activities meet regulatory, corporate, and site quality requirements; partner with Quality and support inspection readiness.
• Manage C&Q changes and deviations, assess impacts against approved scope, and escalate compliance risks.
• Promote and enforce a strong safety culture and compliance with site safety standards and industry best practices.
• Serve as the program C&Q subject matter expert, providing technical direction and coaching to contract and contingent resources without direct reporting authority.
• Identify and drive C&Q improvements that increase efficiency while maintaining compliance; feed lessons learned into GFD CQV standards, methods, and templates.
• Report progress, risks, issues, quality, and compliance status to program leadership and the Senior Director, Asset Delivery.
• Report C&Q metrics, including scope change management, progress and performance, look-aheads, critical path, and resourcing.
• Collaborate across detailed design, project engineering, construction, automation, Quality, Site Operations, and program teams, and take on emerging priorities.

Benefits

• Company bonus eligibility, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefit eligibility.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior