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.

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