Process Engineer, Purification - Lilly Medicine Foundry

Eli Lilly and Company • Indianapolis, IN

21h • Hybrid

About The Position

Lilly is constructing an advanced research facility for production of API molecules for clinical trials located in Lebanon, IN. This facility is Lilly’s largest investment in a clinical trial manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. We are seeking experienced Process Engineers to support purification of biologics, peptides, oligonucleotides, and bioconjugates. This position involves solving technical challenges with equipment design, developing and sustaining process knowledge, optimizing processes, and managing equipment capabilities.

Requirements

• BS or MS in chemical engineering or related discipline and a minimum of 1-4 years of experience with a pharmaceutical, biotech, or CMO environment supporting the process engineering of drug substance active pharmaceutical ingredient (API) manufacturing or development.
• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Deep technical interest and understanding in the field of Chemical Engineering
• Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability
• Experience with any of the following software packages: DeltaV, OSI-PI, Dynochem, Aspen, and/or electronic lab notebooks
• Strong analytical and problem-solving skills
• Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management.
• Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals
• Understanding of process control systems
• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented
• Guidance/mentoring of others through processes
• Flexibility to meet business needs

Responsibilities

• Provides technical assessment and support for production operations in the areas of developing and sustaining process knowledge, process and equipment support, process optimization, equipment capability and asset management, and engineering business systems.
• Serves as a process engineer supporting drug substance active pharmaceutical ingredient (API) manufacturing for biologics, oligonucleotide, peptide, and bioconjugate purification.
• Performs impact and risk assessments for the relevant equipment (chromatography skids/columns, TFF skids, etc.) and unit operations.
• Learns the lab and plant design for the purification equipment including automation recipes and procedures.
• Ensures that people and their environment are safe and that company policies concerning safety are followed.
• Ensures processing equipment remains compliant with internal Quality System requirements, applicable engineering standards, and cGMP requirements.
• Assesses rig fit by receiving the technical data package for new processes and performing modeling, simulations and/or experimental work as required to ensure heat and mass transfer are acceptable when scaling to the plant.
• Actively engages and communicates with: HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing.
• Authors, reviews, or approves high-quality technical reports and regulatory submissions dealing with the work performed by the department.
• Ensures that records and technical notebooks are adequately maintained.
• Demonstrates engagement and employs a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately.
• Develops or reviews plans and timetables for project work.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees