Process Engineer - Automation

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.

Lilly is expanding our manufacturing network with a new, highly automated facility in Concord, North Carolina. This site is designed to support the production of parenteral (injectable) medicines, device assembly, and packaging operations. Using advanced integrated systems and sustainable design, the Concord site will play a critical role in meeting global patient needs.

We are seeking a Process Engineer to support startup, qualification, and ongoing optimization of equipment and processes at this state‑of‑the‑art location.

The Process Engineer will serve as the equipment and process owner for assigned systems within the manufacturing area. This role provides technical leadership, drives reliability and performance, and partners closely with Operations, Maintenance, Engineering, and Quality. You will support commissioning activities, troubleshoot complex equipment issues, implement improvements, and help establish world‑class technical standards as the site scales.

• Serve as responsible owner for the safe and compliant operation of assigned equipment and processes.
• Develop deep technical knowledge of system functionality, equipment flow diagrams, process flow documentation, and key process parameters.
• Monitor and analyze control system and performance data to verify performance, identify trends, and optimize operation.

• Lead advanced troubleshooting for equipment and operational issues, partnering with Maintenance/Engineering Technicians as the second‑line escalation point.
• Apply formal problem‑solving tools (e.g., RCA, 5‑Why) to determine root causes and implement corrective actions.

• Define system and component classifications, maintenance strategies, and reliability improvement plans.
• Participate in periodic equipment reviews and collaborate with site/corporate asset management teams to share improvements across the network.

• Lead or support change controls, deviations, activity plans, and CAPA‑related actions to maintain validated/qualified state.
• Evaluate work activities and modification impacts, ensuring compliance with GMP, safety, and engineering standards.

• Participate in or lead commissioning, IQ/OQ/PQ activities for new equipment and system expansions.
• Act as a user representative on small and large capital projects, providing engineering input into design, installation, and startup phases.

• Identify, propose, and execute improvements, including procedural enhancements, system upgrades, and equipment modifications.
• Benchmark equipment performance against similar operations to identify opportunities.
• Collaborate effectively with Operations, Quality, Maintenance, Technical Services, and external partners.

• Bachelor’s degree in Engineering, Computer Technology, Life Sciences, or a related field.
• Proficiency in data analysis and visualization tools (e.g., Excel, JMP).
• Demonstrated commitment to safe work practices and support of HSE corporate and site goals.

• Experience in pharmaceutical or other GMP‑regulated manufacturing environments.
• Experience working with validated systems and understanding requirements for maintaining validated/qualified state.
• Ability to apply statistical thinking to solve manufacturing or equipment performance challenges.
• Hands‑on experience executing formal root‑cause methodologies…