Senior Process Engineer – Biologics- Lilly Medicine Foundry

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 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. About the Lilly Medicine Foundry: Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. Organizational Overview: Lilly is currently constructing an advanced research facility for production of API molecules for clinical trials located in Lebanon, IN. This facility is Lilly’s largest investment in a clinical trial manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. We are seeking a Senior Process Engineer to support the facility in Lebanon with a focus on biologics drug substance manufacturing, including upstream (cell culture/fermentation) and downstream (purification, filtration, formulation) unit operations. This position involves solving technical challenges with equipment design, developing and sustaining process knowledge, optimizing processes, and managing equipment capabilities. Responsibilities : The Senior Process Engineer provides technical assessment and support for production operations in the areas of developing and sustaining process knowledge, process and equipment support, process optimization, equipment capability and asset management, and engineering business systems. This role is to serve as a process engineer supporting large molecule biologics drug substance active pharmaceutical ingredient (API) manufacturing. Perform impact and risk assessments for unit operations Learn the lab and plant design for the reactors including automation recipes and procedures. Ensure that people and their environment are safe and that company policies concerning safety are followed. Ensure processing equipment remains compliant with internal Quality System requirements, applicable engineering standards, and cGMP requirements. Active engagement and communication with: HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing. Author, review, or approve high-quality technical reports as required to explain basis of design, including facility fit assessments, process characterization, and comparability considerations. Support scale-up/scale-down strategy and troubleshooting for biologics unit operations, incorporating cell culture media/feed strategies, chemical engineering first principles, viral clearance requirements, and contamination control strategies as applicable. Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately. Develop or review plans and timetables for project work. Support and suggest process and equipment improvements and technology advancements to ensure innovative and robust processes are developed. Basic Requirements: BS or MS in chemical engineering, biochemical engineering, or a related discipline and a minimum of 2 years of experience with a pharmaceutical, biotech, or CMO environment supporting the process engineering of biologics drug substance manufacturing or development. Demonstrated experience with upstream and/or downstream biologics unit operations (bioreactors, media prep, centrifugation, chromatography or filtration). 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. Additional Preferences: Deep technical interest and understanding in the field of biologics/bioprocess engineering. Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability. Experience with single-use technology systems and associated engineering considerations. Experience with any of the following software packages: DeltaV, bioreactor SCADA/process chromatography control systems, Dynochem, Aspen, and/or electronic lab notebooks. Familiarity with biologics regulatory submissions (IND, BLA, CTD modules) and process characterization/validation requirements. Strong analytical and problem-solving skills. Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management. Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals.</sp