Principal Process Engineer - API External Manufacturing Small Molecule
$66,000–$171,600 year
HybridIndianapolis, Indiana, United States
Job Summary
Lead API external manufacturing process engineering for small molecule medicines by developing and sustaining process knowledge across multiple contract manufacturers. Direct interactions with CM personnel to execute operational control strategies, assess equipment suitability, and perform FUME risk evaluations. Champion statistical thinking and data-driven decision-making within Joint Process Teams to monitor performance and optimize unit operations for yield and cycle time. Support tech transfers and scale-ups from development through commercial supply, while leading root cause analysis for safety, quality, and throughput incidents. Serve as the liaison for health, safety, and environmental oversight at contract sites, ensuring adherence to Lilly policies and continuous improvement initiatives.
Required Qualifications
- Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive chemical manufacturing experience
- 3+ years of work experience in a manufacturing/process engineering related role related to small molecules
- Qualified applicants must be authorized to work in the United States on a full-time basis
- Experience in typical unit operations for Small 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 process improvement
- Demonstrated ability to function in a team environment as a technical leader and as a member of teams
- Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences
- Process Hazard Analysis experience
- Successful application of root cause analysis and systematic problem solving
- Strong Computer skills in a variety of software packages ( e.g Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office Suite)
- Visualize an operation/process and reflect it in a model
- This role is located onsite in Indianapolis, IN with the ability to work from home up to 4 days per month
- Travel may routinely be required to support process start-ups, troubleshooting, and commercial manufacturing. This travel is typically in the range of 15% to 25% annually, depending on the needs of the process(s)
Desired Qualifications
- Relocation assistance will be provided if applicable
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