Principal Process Engineer, Lilly Medicine Foundry

About the Lilly Medicine Foundry

Lilly is 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 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 part of the startup team for a greenfield manufacturing site, helping to build the processes and facility to enable a successful startup into GMP manufacturing operations.

We are seeking a small molecule Process Engineer to support the pilot plant facility in Lebanon with a focus on active pharmaceutical ingredient synthesis. This position involves solving technical challenges with equipment design, developing and sustaining process knowledge, optimizing processes, and managing equipment capabilities.

Responsibilities

• Provide technical assessment and support for production operations in process knowledge, process and equipment support, process optimization, equipment capability and asset management, and engineering business systems
• Serve as a process engineer supporting small molecule 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
• Assess rig fit by receiving the technical data package for new processes and performing modeling, simulations and/or experimental work to ensure heat and mass transfer are acceptable when scaling to the plant
• Actively engage and communicate 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 and regulatory submissions
• Ensure records and technical notebooks are adequately maintained
• Demonstrate engagement and employ a quality mindset by proactively identifying quality issues and communicating appropriately
• Develop or review plans and timetables for project work

Basic Requirements

• BS or MS in Chemical Engineering or related discipline
• Minimum of 4 years of experience within a pharmaceutical, biotech, chemical manufacturing, or CMO environment or other relevant batch manufacturing process
• 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

Additional Preferences

• Supported manufacturing and/or development activities for active pharmaceutical ingredients, intermediates, or other chemicals
• Deep technical interest and understanding in the field of Chemical Engineering
• Familiarity with unit operations including chemical reactions, distillation, phase separation, filtration, drying
• Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability
• Experience with DeltaV, Dynochem, Aspen, and/or electronic lab notebooks
• Strong analytical and problem-solving skills
• Strong oral and written communication skills for a diverse audience
• Ability to work on own initiative and as part of a Process Team
• Understanding of process control systems
• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented
• Guidance/mentoring of others through processes
• Flexibility to meet business needs