At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
Job Summary: The Program Commissioning and Qualification Sr. Director will be responsible for leading the commissioning and qualification (C&Q) activities for major greenfield site capital projects within the Global Facilities Delivery Projects team. This role involves ensuring that all systems and equipment are properly commissioned and qualified to meet regulatory and business requirements. The lead will work closely with project managers, engineering teams, and site operational readiness to deliver high-quality C&Q programs.

QUALIFICATIONS:

• Bachelor’s degree in Engineering, related science or Project Management, or a related field.
• Minimum of 15 years of experience in commissioning and qualification activities within the pharmaceutical or biotech industry.
• Proven track record of managing large-scale C&Q programs from design phase through to closeout and handover.
• Strong knowledge of ASTM E2500 Model and Verification methodology.

PREFERRED QUALIFICATIONS:

• Excellent leadership, communication, and organizational skills.
• Ability to work effectively in a cross-functional team environment.
• Experience with greenfield site projects and pharmaceutical & process safety processes.
• Familiarity with regulatory requirements and industry standards for commissioning and qualification.
• Certification in project management (PMP or equivalent) is a plus.

• Lead the development of an effective safety programs from procedure development to execution in the field during project C&Q.
• Develop and implement comprehensive C&Q strategies for major capital projects, including parallel commissioning of multiple production facilities and support buildings in a GMP and process safety regulated environment.
• Manage the development of CQ strategies and execution plans, schedule, and budget to ensure timely and cost-effective delivery.
• Provide technical oversight and guidance to the C&Q team, ensuring adherence to industry standards and best practices.
• Coordinate with project managers and teams to assess, provide direction, and oversee the implementation of engineering and construction services.
• Ensure all commissioning packages are approved according to the trace matrix
• Develop and maintain traceability matrices to demonstrate how commissioning testing met user requirements.
• Develop project C&Q organization to support schedule and deliver to budget in collaboration with the Process Equipment COE and other key professional services to maintain a diverse and capable pool of service providers.
• Monitor and understand market conditions to educate and influence project decisions with current data.