Principal Process Engineer - API External Manufacturing (Large Molecule)

Principal Process Engineer – API EM Large Molecule reports to the API EM Engineering Director and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel to ensure the reliable supply and commercialization of medicines with safety first and quality always. Key Objectives / Deliverables Coach and mentor process team members; provide insight and feedback to members of the CM Joint Process Team (JPT). Champion the application of statistical thinking and data analysis to monitor process performance and inform engineering decisions with CM members. Support and peer‑review root cause analysis around FUME and operational incidents. Peer‑review documentation of learning points, technical studies, and incident investigations. Lead or support technology transfer and scale‑up from development through PV and commercial supply; translate process intent into operating strategies, equipment fit/gap, batch documentation, and PV readiness at CMs. Support engineering runs and PV readiness through parameter optimization and performance trending. Identify process knowledge gaps and develop or support the capture of key process knowledge such as material and energy balances, kinetics, chemistry, process modeling, and equipment design basis. Use optimization resources and tools for process analysis and improvement studies; review and track key process engineering metrics. Identify systemic issues affecting production and reliable supply; lead or participate in root cause analysis and countermeasure development for major safety, quality, or throughput incidents. Review and approve documentation and engineering decisions. Support development and technical analysis for ongoing continuous improvement activities; identify cost reduction opportunities, process capacities, and bottlenecks; prioritize opportunities with respect to overall business objectives. Work with CMs to ensure application of statistical thinking and methods to understand process variability and capability; perform and promote optimization of unit operation cycle time, loading, and yield performance. Engage with late‑phase development and Engineering Technical Center resources to stay contemporary with key engineering disciplines and develop portfolio platforms. Create methodology to ensure visibility of qualification status of key FUME systems at CMs; review equipment and process system user requirements and qualification plans. Act as customer representative for review of CM requests for capital projects targeted at short‑ and long‑term needs. Serve as liaison for API EM and Global HSE on health, safety, and environmental (HSE) and process safety management (PSM) oversight at contract manufacturing sites; participate in audits and maintain key metrics. Understand and follow all applicable Lilly policies and procedures with respect to interactions and oversight of API contract manufacturing sites. Basic Requirements Bachelor of Science degree in Chemical Engineering or another engineering discipline. 5+ years of experience in chemical manufacturing. 3+ years of relevant manufacturing/process engineering experience in large molecules. Authorized to work in the United States on a full‑time basis (no sponsorship). Additional Preferences Experience in typical unit operations for large molecule API manufacturing. Deep technical knowledge of API/drug substance manufacturing equipment and unit operations. Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and improvement. Experience in team leadership and communication. Process hazard analysis experience. Root cause analysis and systematic problem‑solving skills. Proficient in software packages such as Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, and MS Office Suite. Other Information Location: Indianapolis, IN (onsite). Remote work possible up to 4 days per month. Relocation assistance provided if applicable. Travel typically 15‑25% of the year for process start‑ups, troubleshooting, and commercial manufacturing. Compensation & Benefits The anticipated wage for this position is $66,000–$171,600. Full‑time employees are eligible for a company bonus. Beneficiaries also have access to a comprehensive benefit program including 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible benefits, life insurance, and well‑being programs. EEO Statement Lilly is proud to be an EEO employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. #J-18808-Ljbffr 100 Eli Lilly and Company