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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Program C&Q Lead - **Company:** Eli Lilly and Company - **Location:** Huntsville, AL, United States - **Experience:** Expert - **Salary:** $159,000.0 - $233,200.0 - **Contract:** Temporary contract - **Skills:** Application Programming Interfaces (APIs), Information Management, Oracle (Applications), Power BI, Strategies of Testing, Smartsheet, Resource Loading, Test Scripts, GXP - **Published:** August 26, 2026 - **Apply:** https://www.biospace.com/logon?PipelinedPage=%2Fjob%2F3070339%2Fsenior-program-c-and-q-lead%3FAction%3DContinueJobApplication%23application-form ## About the Role * 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. ## Description The Senior Program C&Q 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 Senior Program C&Q 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 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. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Beyond Dashboards: Fixing Text-to-SQL with Semantic RAG](https://www.wearedevelopers.com/videos/2036-beyond-dashboards-fixing-text-to-sql-with-semantic-rag) - [Quantum DevOps - Enabling Industrial Engineering](https://www.wearedevelopers.com/videos/100282-quantum-devops-enabling-industrial-engineering) - [REST, GraphQL, gRPC, and more: A comparison of modern API styles](https://www.wearedevelopers.com/videos/100247-rest-graphql-grpc-and-more-a-comparison-of-modern-api-styles) - [Hands-on Journey to Quantum Computing with IBM](https://www.wearedevelopers.com/videos/137-hands-on-journey-to-quantum-computing-with-ibm) - [Data Analytics with Microsoft Fabric: End-to-End Use Case with Data Agents](https://www.wearedevelopers.com/videos/1547-data-analytics-with-microsoft-fabric-end-to-end-use-case-with-data-agents) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Best US AI Conferences for CTOs in 2026: Build vs. Buy, Vendor Evaluation, and Peer Intelligence](https://www.wearedevelopers.com/magazine/736-best-us-ai-conferences-for-ctos-in-2026-build-vs-buy-vendor-evaluation-and-peer-intelligence) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer) - [Best Companies to work for in London: Top 25 Companies in 2023](https://www.wearedevelopers.com/magazine/187-best-companies-to-work-for-in-london-top-25-companies-in-2023) - [The Fastest-Growing Tech Sectors to Look Out for in 2025](https://www.wearedevelopers.com/magazine/373-the-fastest-growing-tech-sectors-to-look-out-for-in-2025) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers)