Commissioning & Qualification (C&Q) Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Global Facilities Delivery (GFD) Organization, part of Manufacturing & Quality, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of project management, engineering, construction, and qualification contractors. Many of the assets delivered focus on medical innovation and delivering innovative solutions to patients. Some of the assets delivered will expand the supply of existing medicines or strengthen the supply chain.

The C&Q Program 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 C&Q Program Lead is Lilly's technical owner and single point of accountability for C&Q on the program.

Key Responsibilities

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.

Qualifications Required

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; site-based program assignments may require extended field deployment.

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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Preferred

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 ($100 million+ in total installed cost).

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 tools such as validation / commissioning platforms (e.g., Kneat), Oracle Unifier, Smartsheet, and Power BI.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$159,000 - $233,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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