Senior Program C&Q Lead

Lilly • Richmond, VA

3d • $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 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 is part of Lilly’s Global Facilities Delivery organization, which delivers new and renovated capital assets around the world.

The lead develops and implements program C&Q strategies, plans, schedules, system boundaries, classifications, scope, and turnover structures. They coordinate C&Q sequencing with construction, automation, and startup, forecast resource needs, and secure contingent and contract resources. They direct day-to-day field execution through C&Q firms and contingent node leads; coordinate mechanical completion turnover, punch-list closeout, pre-commissioning, utilities, and construction-to-commissioning control transitions; and plan and lead Factory Acceptance Testing (FAT), including vendor-site witness testing and resolution of findings.

The position authors, reviews, and approves C&Q protocols, test scripts, deviations, and reports; supports structured information capture and turnover through Project Information Management; and leads or supports system handover to User teams and Site Operations. The lead ensures regulatory, corporate, site-quality, and safety requirements are met, manages changes and deviations, supports inspection readiness, provides technical direction and coaching without direct authority, drives continuous improvement, and reports C&Q progress, risks, metrics, and resource needs to program leadership and the Senior Director, Asset Delivery.

The role requires approximately 35% travel within and outside the United States. Site-based assignments may require extended field deployment. Applicants must be authorized to work full-time in the United States; Lilly will not sponsor work authorization or visas for this role.

Requirements

• Bachelor’s degree 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.
• 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%; site-based assignments may require extended field deployment.
• Authorization 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.
• Proven 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.
• Experience with CQV 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, system classification, C&Q scope, and turnover package structure to ensure appropriate testing without gaps or duplication.
• Build and maintain the integrated C&Q schedule, including critical path analysis, 2–4 week look-aheads, and resource loading; integrate sequencing with construction, automation, and startup milestones.
• Forecast C&Q resource demand and partner 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, installation of consumables, 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 LOTO and the transition of systems from construction control to commissioning control.
• Plan and lead program FAT, including test strategy, protocol review and approval, schedules, and coordination with vendors, engineering, and construction.
• Witness FAT at vendor sites, disposition findings and deviations, and confirm resolution before equipment is released to site.
• Author, review, and approve C&Q protocols, test scripts, deviations, and summary reports; promote 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 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 change and deviation processes, assess impacts against approved scope, and escalate compliance risks.
• Enforce site safety standards and industry best practices for C&Q activities 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 and implement C&Q improvements that increase efficiency while maintaining compliance; feed lessons learned into GFD CQV standards, methods, and templates.
• Report progress, risks, issues, quality, compliance risk, and C&Q metrics to program leadership and the Senior Director, Asset Delivery.
• 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