Principal Process Engineer - API External Manufacturing Small Molecule
Eli Lilly and Company
September 08, 2026
Full-time
On-site
Indianapolis, IN
Operations
Role: Principal Process Engineer - API EM Small Molecule, providing technical leadership in the reliable supply and commercialization of small molecule APIs. Responsibilities include developing process knowledge, supporting scale-up and tech transfer, overseeing equipment qualification, process optimization, and troubleshooting at contract manufacturing sites. The role also involves mentoring process teams, ensuring HSE and PSM compliance, and managing process improvements for cost and capacity efficiency. Key tasks include process validation, risk assessment, and maintaining process capability. Qualifications: Bachelor's in Chemical Engineering or related field, 3+ years in small molecule process/ manufacturing engineering, with deep knowledge of API production equipment and operations. Preferred skills include experience with unit operations, process hazard analysis, root cause analysis, and proficiency in relevant software tools like Aspen, JMP, and OSI PI. The position requires onsite presence in Indianapolis, IN, with up to 25% travel for process start-ups and troubleshooting. High-value specifics: small molecule API manufacturing, process validation, scale-up, process safety, and quality oversight, with a focus on continuous improvement and technical leadership within a regulated GxP environment.