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 Responsibilities Technical 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 Proven track record leading and providing oversight to large-scale C&Q programs concurrently, from design phase through closeout and handover. Demonstrated ability to mentor, coach and develop C&Q Leads and project teams, and to achieve results and influence through people without direct supervisory relationships. Strong project-management capability across scope, schedule, budget and risk on major and mega capital programs. Ability to frame complex decisions, facilitate to resolution and implement according to plan, aligning stakeholders who hold differing opinions across sites, corporate engineering, A/E firms and contract partners. Strong knowledge of the ASTM E2500 Model and risk-based verification methodology, and familiarity with industry standards and regulatory expectations for C&Q. Excellent written and verbal communication skills with both technical and non-technical audiences, and strong interpersonal skills within multi-discipline teams. Demonstrated willingness to embrace continuous improvement and act as an agent for change. Project Management Professional (PMP), or equivalent certification is a plus. Experience working and/or living outside the U.S., and competency in a foreign language, is an advantage. Work Environment & Travel Regular collaboration with Project Managers, Design Leads, engineering teams, automation, construction, quality assurance and professional-services partners across the assigned portfolio. Role may be based at a Lilly EU or US manufacturing site; on-site presence at assigned project locations is expected during key C&Q phases. Domestic and international travel is likely, including occasional weekends and multi-week stays, of approximately 15% to 25% depending on portfolio and project phase. Additional Information This is a banded position; formal job titles are assigned to each level internally upon hire and may differ from the posting title. Note: When applying internally for a position, your current supervisor receives notification that you have applied. We encourage employees to discuss the opportunity with their supervisor prior to applying. 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 $130,500 - $211,200 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. #WeAreLilly