Eli Lilly

Commissioning & Qualification (C&Q) Lead

Eli Lilly • $159K — $233K *
Huntsville, AL 35810In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's in Engineering, Life Sciences, or a related field.
  • 15+ years of CQV experience in GMP-regulated environments with capital project leadership.
  • Hands-on experience across the validation lifecycle including startup support.
  • Experience planning and executing Factory Acceptance Testing (FAT).
  • Willingness to travel approximately 35%, with potential extended deployments; requires US work authorization.

Responsibilities

  • Create and implement the C&Q strategy and plans aligned to CQV standards.
  • Define system boundaries and commissioning scope for efficient testing.
  • Maintain an integrated C&Q schedule and perform critical path analysis.
  • Direct day-to-day C&Q execution and ensure adherence to programs.
  • Coordinate pre-commissioning activities and manage mechanical completion turnover.
  • Lead and witness Factory Acceptance Testing (FAT), ensuring equipment readiness.
  • Author and review qualifying documentation, ensuring audit readiness.

Benefits

  • Eligibility for a company-sponsored 401(k) and pension plan.
  • Vacation benefits and various leave of absence options.
  • Medical, dental, vision, and prescription drug benefits.
  • Flexible spending accounts for healthcare and dependent care.
  • Life insurance and death benefits, along with wellness program benefits.
Full Job Description
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.

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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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