Principal Automation Engineer – Computer System Validation

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. 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 40,000 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 building a next-generation biotech drug substance manufacturing facility in Richmond, VA - our most technically advanced site to date. This greenfield facility will feature cutting-edge manufacturing technologies and advanced data platforms designed to drive improvements in safety, quality, and productivity. This is a rare opportunity to shape an organization, a facility, and a culture from the ground up.

The Principal Automation Engineer – Computer System Validation is a mid-level automation engineering position that requires a deep understanding of process automation systems, Lilly's computer system validation practices, cGMP standards related to computer systems, and data integrity as they relate to pharmaceutical manufacturing. This role will support the design and delivery of process automation systems including requirements, verification plans, validation plans, and strategies for overall computer system validation.

This role will also be integral in the development of computer system validation plans for process automation systems (DCS and PLC based), Building Management Systems, and supporting systems including data historians and other central automation platforms. During the design and delivery (startup activities expected 2029 to 2030) of the project this role will be integrated into the corporate automation team GPACE (Global Process Automation & Control Engineering) and then transition fully to a site-based process team position.

During delivery, this role will collaborate with Lilly Quality, A&E firms, system integrators, and corporate and site engineering peers. Post-project delivery, this role will support GMP manufacturing operations in the central engineering function supporting one or more process teams. This role will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing site through start up.

• Champion a strong safety culture, mentor and coach others, and utilize engineering and automation fundamental principles in design and problem solving.
• Become a subject matter expert on Lilly Quality Standards & Procedures that apply to Process Automation systems including requirements, design, and testing with a focus on the API / Drug Substance network
• Collaborate with Lilly’s Quality organization, Corporate Engineering, and Global Facilities Delivery to develop Computer System and Process Automation qualification and testing strategies.
• Lead and direct a contingent workforce team to support…