Advisor - Commissioning & Qualification - GFD

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.
Organization Overview
The Global Facilities Delivery (GFD) Organization, part of Corporate Engineering, delivers new and renovated capital assets around the world. Our mission is accomplished through a highly leveraged organization of design, 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.
This is a central, portfolio-facing role within GFD. The Central C&Q Lead provides technical leadership, program oversight, mentorship and escalation support across a portfolio of assigned major and mega capital projects, ensuring consistent, compliant and efficient C&Q delivery.
Role Summary
The GFD Central C&Q Lead is a senior technical leadership position responsible for setting strategy, standardization and successful C&Q delivery across a portfolio of assigned major and mega capital projects.
The Central C&Q Lead is expected to be a subject-matter authority in the delivery of C&Q for new facilities and brings a deep, first-hand knowledge of the full project lifecycle — from conceptual design through construction, FAT/SAT, field commissioning / verification, system turnover, and closeout — and applies that expertise to guide project C&Q Leads and their teams to a high bar of Safety First and Quality Always.
The Central C&Q Lead operates across the assigned portfolio by championing C&Q strategy, coaching and mentoring project teams, driving consistency of approach and tooling, and serving as the primary point of technical and program escalation when issues on assigned projects cannot be resolved locally. The role reports to the GFD C&Q Senior Director and works in close partnership with Project Managers, Design Leads, Engineering SME’s, QA, and other professional-services partners.
Key ResponsibilitiesTechnical Leadership Across the Project Lifecycle
Serve as the C&Q technical authority for assigned major and mega facilities, providing lifecycle oversight from conceptual/basic design through construction, FAT/SAT, field commissioning and verification execution (receipt, installation and operational verification), system turnover and closeout.
Ensure a working technical understanding of the systems, utilities and process equipment expected in assigned porfolio — GMP and process-safety regulated — so that C&Q strategy, risk assessment and test coverage are appropriate and defensible.
Guide the definition of C&Q strategy and execution plans on each assigned project, including parallel commissioning of multiple production facilities and support buildings, and confirm alignment with the integrated project schedule and budget.
Champion the Lilly C&Q methodology and execution across portfolio
Program & Strategy Oversight
Oversee the C&Q strategy for assigned projects at a portfolio level, ensuring each project's approach is consistent with GFD business processes, industry standards and regulatory expectations while remaining fit for the specific asset.
Drive standardization and reuse of C&Q approaches, templates, tools and lessons learned across projects to improve quality, speed and cost-effectiveness of delivery.
Monitor and improve performance by defining, tracking and reporting C&Q metrics across the assigned portfolio, translating insights into actions that drive continuous improvement.
Mentorship & Capability Development
Coach and mentor project C&Q Leads and their teams on strategy, execution, risk-based verification, and day-to-day program management, building bench strength across GFD.
Transfer knowledge and train project teams and service providers on the Lilly C&Q program to a level of detail sufficient for effective implementation in the field.
Develop others through structured coaching, on-the-job guidance and honest feedback, actively growing the next generation of C&Q leaders — sometimes external to the organization.
Escalation & Issue Resolution
Act as the primary point of escalation for C&Q strategy and program issues on assigned projects — leading resolution of matters that cannot be settled locally, including delayed document approvals, field-execution issues, and cross-discipline alignment problems.
Facilitate rapid, structured resolution of technical and compliance questions by convening the right stakeholders (end-user representatives, construction, automation, QA, project controls) and driving decisions to closure.
Represent C&Q at project leadership forums for assigned projects, surfacing risks and issues early and influencing decisions with current, data-driven insight.
Project Management & Delivery
Provide oversight of C&Q scope, schedule and budget across assigned projects, ensuring the C&Q scope is delivered on time, within budget and to the required quality standards.
Support planning of execution strategy and logistics for test-case development and field execution
Apply a disciplined, structured approach to program management, compliant with Company Policies and Procedures.
Safety, Quality & Stakeholder Interface
Uphold a Safety First and Quality Always culture, ensuring C&Q teams abide by project safety requirements and that C&Q-specific safety, permitting and method-statement practices are in place.
Collaborate across the organization with Project Managers, Design Leads, engineering, automation, construction, QA and business partners to fully understand scope and delivery approach and to influence outcomes without direct supervisory authority.
Partner with GFD C&Q leadership to shape and continuously improve GFD's C&Q business processes, procedures and training, and to ensure market conditions and current data inform project decisions.
Basic Requirements
Bachelor of Science in Engineering, related science, Project Management or a related field.
Minimum of 15 years of Commissioning & Qualification experience within major or mega pharmaceutical capital project delivery.
Direct experience executing C&Q test cases and methodologies, including receipt, installation and operational verification.
Experience as a C&Q Manager/Lead across the full lifecycle of at least one brownfield or greenfield pharmaceutical facility — from early design and team formation through field execution, system turnover and closeout.
Working knowledge of GMP, process safety and regulatory requirements for commissioning and qualification, and of the ASTM E2500 Verification approach.
Experience with electronic C&Q documentation systems such as Kneat™ and an understanding of how such tools interact with the C&Q process.
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.
Additional Preferences

Skills
Project Management, Documentation