Senior Program C&Q Lead

Lilly • Houston, TX

5d • $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 serves as Lilly’s technical owner and single point of accountability for C&Q, setting strategy, directing field execution, and delivering systems that are validated, GMP-compliant, and ready for reliable startup and handover to Site Operations.

The role develops C&Q plans, scopes, schedules, and resource forecasts; coordinates field execution, pre-commissioning, construction turnover, and Factory Acceptance Testing; and authors, reviews, and approves qualification documentation. It ensures compliant, audit-ready records and asset information, supports system handover, manages quality and safety risks, and reports progress and metrics to program leadership and the Senior Director, Asset Delivery. The position collaborates across engineering, construction, automation, Quality, Site Operations, contractors, vendors, and other program teams, and provides technical direction to C&Q resources without direct reporting authority. Travel within and outside the United States is expected at approximately 35%; site-based program assignments may require extended field deployment.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• At least 15 years of 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 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 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.
• Build and maintain the integrated C&Q schedule, including critical path analysis, 2–4 week look-aheads, resource loading, and coordination 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, including utility priming, instrument calibration, automation downloads, consumables installation, and VFD setup.
• Coordinate temporary power and utility demand across nodes and with site utilities, including wastewater discharge and drain and sump loading.
• Partner with mechanical and construction teams on LOTO and the transition from construction control to commissioning control.
• Plan and lead program FAT, including defining test strategy, reviewing and approving protocols, setting schedules, and coordinating vendors, engineering, and construction.
• Witness FAT at vendor sites, disposition findings and deviations, and confirm resolution before 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 engineering and asset information is captured and turned over through Project Information Management, including specifications, drawings, test records, as-builts, and handover data packages.
• Lead or support system handover to the User team 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 change and deviation processes, assess impact against approved scope, and escalate compliance risks.
• Enforce site safety standards and industry best practices and promote a safe working environment.
• Serve as the program C&Q subject matter expert and provide technical direction and coaching to contract and contingent resources without direct reporting authority.
• Identify opportunities to improve C&Q practices while maintaining compliance, and feed lessons learned into GFD CQV standards, methods, and templates.
• Report progress, risks, issues, C&Q status, quality, and compliance risks to program leadership and the Senior Director, Asset Delivery.
• Report program C&Q metrics, including change management against initial scope, progress and performance measurement, look-aheads, critical path analysis, and resourcing.
• Collaborate across detailed design, project engineering, construction, automation, Quality, Site Operations, and program teams, and take on emerging priorities.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, such as 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