Senior / Principal Process Engineer - API External Manufacturing Peptides
Eli Lilly and Company
4 hours ago
On-site
Indianapolis, IN
$66,000 - $171,600 USD yearly
Operations
Position: API EM Engineer [Synthetic Peptide Synthesis and Purification]
Responsibilities
- Develop and sustain process knowledge to execute appropriate product, process, and operational control strategy at multiple Contract Manufacturers (CMs).
- Interact with CM personnel to ensure reliable supply via execution of the operational control strategy.
- Perform FUME assessments to understand risk to the operational control strategy.
- Participate in equipment specification, procurement, and IQ/OQ/PQ with internal/CM resources.
- Assess HSE and PSM elements at CMs that impact Lilly products; adhere to Lilly Red Book expectations.
- Support development of capabilities with new/evolving technologies impacting portfolio delivery.
- Coach and mentor Process Team members; provide insight/feedback to CM Joint Process Team (JPT).
- Champion statistical thinking and use of data to monitor process performance and support engineering decisions.
- Support/peer review root cause analysis for FUME and operational incidents; peer review learning points, technical studies, and incident investigations.
- Lead/support tech transfers and scale-up from development through PV and commercial supply; translate process intent into operating strategies, equipment fit/gap, batch documentation, and PV readiness.
- Support engineering runs and PV readiness via parameter optimization and performance trending.
- Identify process knowledge gaps; capture/maintain key process knowledge (e.g., balances, kinetics, modeling, equipment design basis).
- Identify systemic production/reliable supply issues at CMs; lead/participate in major safety/quality/throughput incident RCA and countermeasure implementation.
- Review/approve documentation and engineering decisions.
- Support continuous improvement: cost reduction opportunities, capacities/bottlenecks, prioritize per business objectives; optimize cycle time, loading, and yield.
- Create methodology to ensure visibility of ongoing qualification state of key FUME systems; review user requirements/qualification plans; act as customer representative for CM capital project requests.
- Liaison for HSE/PSM oversight with Global HSE at CM sites; leverage internal experts, participate in audits, maintain key HSE/PSM metrics.
- Follow applicable Lilly policies/procedures for API contract manufacturing site interactions/oversight (e.g., FRAP, Lilly Red Book, standards, Quality policies).
Basic Requirements
- 3+ years in manufacturing/process engineering related to peptides or small molecules.
- Demonstrated scale-up and/or technology transfer experience (plant or external CMO).
- BS in Chemical Engineering or another engineering discipline with extensive chemical manufacturing experience.
- Authorization to work in the United States full-time; Lilly does not sponsor visas.
Additional Preferences
- Experience with SM/peptide unit operations and purification/isolation for drug substance manufacturing.
- Experience with typical API manufacturing unit operations.
- Deep technical knowledge of API/drug substance manufacturing equipment and unit operations.
- Apply chemical engineering principles to process understanding, problem solving, and improvement.
- Function as a technical leader; manage/prioritize competing priorities; communicate verbally and in writing.
- Innovative problem-solving; Process Hazard Analysis experience.
- Root cause analysis and systematic problem solving.
- Proficiency in software (e.g., Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office Suite).
- Ability to visualize operations/processes in models.
Other Information (Work Expectations)
- Monday–Friday, 8 hours/day; teleconferences may occur outside hours. OUS travel may be required ~15–25% annually.
- Must complete assigned training curriculum; no certifications required.
- Tasks require entering manufacturing and laboratory areas and wearing PPE.
Benefits
- Full-time employees are eligible for a company bonus (based on company/individual performance) and a comprehensive benefits program (e.g., 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits).
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Responsibilities
- Develop and sustain process knowledge to execute appropriate product, process, and operational control strategy at multiple Contract Manufacturers (CMs).
- Interact with CM personnel to ensure reliable supply via execution of the operational control strategy.
- Perform FUME assessments to understand risk to the operational control strategy.
- Participate in equipment specification, procurement, and IQ/OQ/PQ with internal/CM resources.
- Assess HSE and PSM elements at CMs that impact Lilly products; adhere to Lilly Red Book expectations.
- Support development of capabilities with new/evolving technologies impacting portfolio delivery.
- Coach and mentor Process Team members; provide insight/feedback to CM Joint Process Team (JPT).
- Champion statistical thinking and use of data to monitor process performance and support engineering decisions.
- Support/peer review root cause analysis for FUME and operational incidents; peer review learning points, technical studies, and incident investigations.
- Lead/support tech transfers and scale-up from development through PV and commercial supply; translate process intent into operating strategies, equipment fit/gap, batch documentation, and PV readiness.
- Support engineering runs and PV readiness via parameter optimization and performance trending.
- Identify process knowledge gaps; capture/maintain key process knowledge (e.g., balances, kinetics, modeling, equipment design basis).
- Identify systemic production/reliable supply issues at CMs; lead/participate in major safety/quality/throughput incident RCA and countermeasure implementation.
- Review/approve documentation and engineering decisions.
- Support continuous improvement: cost reduction opportunities, capacities/bottlenecks, prioritize per business objectives; optimize cycle time, loading, and yield.
- Create methodology to ensure visibility of ongoing qualification state of key FUME systems; review user requirements/qualification plans; act as customer representative for CM capital project requests.
- Liaison for HSE/PSM oversight with Global HSE at CM sites; leverage internal experts, participate in audits, maintain key HSE/PSM metrics.
- Follow applicable Lilly policies/procedures for API contract manufacturing site interactions/oversight (e.g., FRAP, Lilly Red Book, standards, Quality policies).
Basic Requirements
- 3+ years in manufacturing/process engineering related to peptides or small molecules.
- Demonstrated scale-up and/or technology transfer experience (plant or external CMO).
- BS in Chemical Engineering or another engineering discipline with extensive chemical manufacturing experience.
- Authorization to work in the United States full-time; Lilly does not sponsor visas.
Additional Preferences
- Experience with SM/peptide unit operations and purification/isolation for drug substance manufacturing.
- Experience with typical API manufacturing unit operations.
- Deep technical knowledge of API/drug substance manufacturing equipment and unit operations.
- Apply chemical engineering principles to process understanding, problem solving, and improvement.
- Function as a technical leader; manage/prioritize competing priorities; communicate verbally and in writing.
- Innovative problem-solving; Process Hazard Analysis experience.
- Root cause analysis and systematic problem solving.
- Proficiency in software (e.g., Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office Suite).
- Ability to visualize operations/processes in models.
Other Information (Work Expectations)
- Monday–Friday, 8 hours/day; teleconferences may occur outside hours. OUS travel may be required ~15–25% annually.
- Must complete assigned training curriculum; no certifications required.
- Tasks require entering manufacturing and laboratory areas and wearing PPE.
Benefits
- Full-time employees are eligible for a company bonus (based on company/individual performance) and a comprehensive benefits program (e.g., 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits).
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation