Principal Process Engineer - API External Manufacturing Small Molecule
Eli Lilly and Company
August 25, 2026
Remote friendly (Indianapolis, IN)
United States
Operations
Position: Principle Process Engineer - API EM (Small Molecule)
Responsibilities:
- Provide technical leadership with API EM contract manufacturer personnel to ensure reliable supply and commercialization with safety/quality.
- Develop and sustain process knowledge and oversee product/process/operational control strategy at contract manufacturers (CMs).
- Assess equipment suitability for process validations; support IQ/OQ/PQ and equipment specification/procurement.
- Perform FUME risk assessment and support HSE/PSM oversight at CM sites; liaison between API EM and Global HSE.
- Lead/support tech transfers and scale-up through PV and commercial supply; translate process intent into operating strategies, batch documentation, and PV readiness.
- Coach/mentor process team members; champion statistical thinking, data monitoring, and performance trending.
- Support root cause analysis, countermeasures, and incident documentation review; review/approve engineering decisions.
- Perform process optimization/continuous improvement: cycle time, loading, yield, variability/capability, and cost reduction opportunities.
- Manage equipment capability/asset management for qualification visibility of key FUME systems; act as CM capital-project customer representative.
Qualifications (Required):
- B.S. in Chemical Engineering (or related with extensive chemical manufacturing experience).
- 3+ years in manufacturing/process engineering for small molecules.
- U.S. work authorization required; Lilly does not sponsor visas.
Preferences:
- Small-molecule API unit operations experience; deep API/drug-substance equipment knowledge.
- Chemical engineering principles for process understanding/problem solving.
- Leadership teamwork; ability to prioritize and communicate.
- Process Hazard Analysis; root cause analysis.
- Strong software skills (e.g., Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office); ability to model/visualize operations.
Benefits (as stated):
- Company bonus (eligibility); comprehensive benefits incl. 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits.
Other: Onsite in Indianapolis, IN; remote up to 4 days/month; travel ~15–25% annually.
Responsibilities:
- Provide technical leadership with API EM contract manufacturer personnel to ensure reliable supply and commercialization with safety/quality.
- Develop and sustain process knowledge and oversee product/process/operational control strategy at contract manufacturers (CMs).
- Assess equipment suitability for process validations; support IQ/OQ/PQ and equipment specification/procurement.
- Perform FUME risk assessment and support HSE/PSM oversight at CM sites; liaison between API EM and Global HSE.
- Lead/support tech transfers and scale-up through PV and commercial supply; translate process intent into operating strategies, batch documentation, and PV readiness.
- Coach/mentor process team members; champion statistical thinking, data monitoring, and performance trending.
- Support root cause analysis, countermeasures, and incident documentation review; review/approve engineering decisions.
- Perform process optimization/continuous improvement: cycle time, loading, yield, variability/capability, and cost reduction opportunities.
- Manage equipment capability/asset management for qualification visibility of key FUME systems; act as CM capital-project customer representative.
Qualifications (Required):
- B.S. in Chemical Engineering (or related with extensive chemical manufacturing experience).
- 3+ years in manufacturing/process engineering for small molecules.
- U.S. work authorization required; Lilly does not sponsor visas.
Preferences:
- Small-molecule API unit operations experience; deep API/drug-substance equipment knowledge.
- Chemical engineering principles for process understanding/problem solving.
- Leadership teamwork; ability to prioritize and communicate.
- Process Hazard Analysis; root cause analysis.
- Strong software skills (e.g., Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office); ability to model/visualize operations.
Benefits (as stated):
- Company bonus (eligibility); comprehensive benefits incl. 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits.
Other: Onsite in Indianapolis, IN; remote up to 4 days/month; travel ~15–25% annually.