Senior / Principal Process Engineer - APIEM

Role Summary

Senior / Principal Process Engineer - APIEM at Lilly. Provides technical leadership and expertise in conjunction with API EM contract manufacturers to ensure reliable supply and commercialization of medicines, with safety first and quality always. Develops process knowledge, leads or participates in equipment qualification, and drives process optimization and continuous improvement across contract manufacturing sites.

Responsibilities

• Developing and sustaining process knowledge to ensure execution of the appropriate product, process, and operational control strategy at multiple Contract Manufacturers (CMs).
• Direct and indirect interaction with CM personnel to ensure reliable supply via CM execution of the operational control strategy.
• FUME assessment to understand risk presented to the operational control strategy.
• Participation with internal or CM resources in equipment specification, procurement, and IQ/OQ/PQ.
• Participation with internal and CM resources to assess HSE and PSM elements of the CM that impact Lilly products.
• Engaged with internal and external resources to develop capabilities with new or evolving technologies impacting portfolio assets.
• Adherence to Lilly Red Book expectations when interacting with API EM’s CMs.
• Coach and mentor Process Team Members, providing insights on unit operation control and statistical thinking to monitor process performance.
• Support and peer review root cause analyses around FUME and operational incidents; peer review documentation of learning points and investigations.
• Identify process knowledge gaps and develop or support capture of key process knowledge (materials/energy balances, kinetics, chemistry, process modeling, equipment design basis).
• Enable development and maintenance of process knowledge infrastructure (models, history, lab models, literature) and utilize optimization tools for analysis and improvement.
• Identify systemic issues affecting production and reliable supply from CMs; lead or participate in root cause analyses and countermeasure implementation for safety, quality, or throughput incidents.
• Review and approve documentation and engineering decisions; ensure appropriate risk reduction across HSE/PSM at CMs.
• Support continuous improvement activities; identify cost reduction opportunities, bottlenecks, and opportunities aligned with business objectives.
• Work with CMs to apply statistical thinking to understand process variability and capability; optimize unit operation cycle time, loading, and yield.
• Engage with late phase development and Engineering Technical Center resources to stay current with key engineering disciplines and portfolio platforms (e.g., continuous manufacturing).
• Create methodologies to ensure visibility of the qualification state of key FUME systems at CMs; review user requirements and qualification plans for equipment and systems.
• Act as customer representative for CM capital project reviews for 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 CM sites; participate in audits as applicable; maintain HSE/PSM metrics.
• Understand and follow Lilly policies and procedures related to API CM sites (FRAP, Red Book, engineering standards, quality policies, etc.).

Qualifications

• Required: 3 years of work experience in a manufacturing/process engineering related role.
• Required: Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive chemical manufacturing experience.
• Preferred: Experience in typical unit operations for API manufacturing; deep technical knowledge of API/Drug Substance manufacturing equipment and unit operations; strong application of chemical engineering principles to process understanding and improvement.
• Preferred: Ability to function as technical leader within a team; strong communication skills; ability to manage and prioritize competing priorities; experience with root cause analysis and problem solving; knowledge of process hazard analysis.
• Preferred: Proficiency with software tools (e.g., Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office Suite) and capability to model operations/processes.

Skills

• Strong problem-solving and analytical abilities; proficiency in applying statistical thinking to process improvement.
• Technical leadership and collaboration with internal and external teams; effective communication to diverse audiences.
• Proficiency with process modeling, data analysis, and engineering documentation.
• Computer skills across a range of scientific and engineering software packages.

Education

• Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive chemical manufacturing experience.

Additional Requirements

• The normal schedule is Monday-Friday, 8 hours/day, with possible teleconferences outside standard hours due to CM time zones. Travel outside the U.S. may be required to support process start-ups, troubleshooting, and manufacturing, typically 15% to 25% annually.
• Must complete assigned training curriculum. No certifications required.
• Work requires entering manufacturing and laboratory areas and wearing appropriate PPE.