Senior Process Engineer – Biologics- Lilly Medicine Foundry
About The Position
Lilly is hiring a Senior Process Engineer to support biologics drug substance manufacturing at the Lilly Medicine Foundry, an advanced research and manufacturing facility being built in Lebanon, Indiana. The role supports upstream operations such as cell culture and fermentation, and downstream operations such as purification, filtration, and formulation. The successful candidate will help establish processes and facility capabilities for startup into GMP manufacturing operations. The position provides technical assessment and production support, including developing and sustaining process knowledge, supporting processes and equipment, optimizing operations, and managing equipment capabilities and assets. The engineer will address technical challenges related to equipment design and process performance, contribute to safe and compliant operations, and work with teams across quality, engineering, development, and manufacturing. The initial work location is Parkwood West in Indianapolis, with a permanent location at the Lilly Medicine Foundry in Lebanon, Indiana.
Requirements
- BS or MS in chemical engineering, biochemical engineering, or a related discipline.
- At least 2 years of experience in a pharmaceutical, biotech, or CMO environment supporting process engineering for biologics drug substance manufacturing or development.
- Demonstrated experience with upstream and/or downstream biologics unit operations, such as bioreactors, media preparation, centrifugation, chromatography, or filtration.
- Must be authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.
Nice To Haves
- Deep technical interest and understanding in biologics or bioprocess engineering.
- Ability to work well in a team across diverse functional relationships and willingness to be a point of accountability.
- Experience with single-use technology systems and related engineering considerations.
- Experience with DeltaV, bioreactor SCADA or process chromatography control systems, Dynochem, Aspen, and/or electronic lab notebooks.
- Familiarity with biologics regulatory submissions, including IND, BLA, and CTD modules, and with process characterization and validation requirements.
- Strong analytical and problem-solving skills.
- Strong oral and written communication skills for diverse audiences, including operations staff and management.
- Ability to work independently and as part of a diverse Process Team of management, production, science, and engineering professionals.
- Understanding of process control systems relevant to biologics unit operations.
- Creativity in identifying improvement opportunities and initiative to implement them.
- Ability to guide or mentor others through processes.
- Flexibility to meet business needs.
Responsibilities
- Perform impact and risk assessments for unit operations.
- Learn the laboratory and plant design for reactors, including automation recipes and procedures.
- Help ensure people and their environment are safe and that company safety policies are followed.
- Ensure processing equipment complies with internal Quality System requirements, applicable engineering standards, and cGMP requirements.
- Engage and communicate with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing.
- Author, review, or approve technical reports explaining the basis of design, including facility fit assessments, process characterization, and comparability considerations.
- Support scale-up and scale-down strategies and troubleshoot biologics unit operations, incorporating media and feed strategies, chemical engineering principles, viral clearance requirements, and contamination control as applicable.
- Proactively identify quality issues and communicate them appropriately.
- Develop or review plans and timetables for project work.
- Support and recommend process and equipment improvements and technology advancements.
Benefits
- Company bonus, depending in part on company and individual performance.
- Eligibility to participate in a company-sponsored 401(k).
- Pension.
- Vacation benefits.
- Eligibility for medical, dental, vision, and prescription drug benefits.
- Flexible benefits, such as healthcare and/or dependent day care flexible spending accounts.
- Life insurance and death benefits.
- Certain time-off and leave-of-absence benefits.
- Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
