Principal Process Engineer - Purification, Lilly Medicine Foundry

About the role

Lilly is seeking experienced Process Engineers to support the purification of biologics, peptides, oligonucleotides, and bioconjugates. This role involves solving technical challenges with equipment design, developing and sustaining process knowledge, optimizing processes, and managing equipment capabilities. The successful candidate will help build the processes and facility to enable a successful startup into GMP manufacturing operations.

Responsibilities

• Perform impact and risk assessments for relevant equipment (chromatography skids/columns, TFF skids, etc.) and unit operations
• Drive progression of design, qualification supporting documentation, and delivery of purification equipment
• Represent the process engineering team in Facility Acceptance Testing for assigned equipment
• Participate in automation recipe and procedure discussions, providing direction on how the equipment needs to be operated to deliver processes
• Mentor junior engineers and drive team technical projects
• Demonstrate a safety-first mindset and ensure that people and their environment are safe and that company policies concerning safety are followed
• Audit 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
• Engage and communicate with: HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing
• Author, review, or approve high-quality technical reports and regulatory submissions dealing with the work performed by the department
• Ensure that records and technical notebooks are adequately maintained
• Proactively identify quality issues and communicate appropriately
• Develop or review plans and timetables for project work

Requirements

• BS or MS in chemical engineering or related discipline and a minimum of 5 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

Qualifications

• Deep technical interest and understanding in the field of Chemical Engineering
• Knowledge and experience with equipment and control strategies for the following unit operations: reverse phase chromatography, column packing, anion exchange chromatography, fractionation, solvent based processing, tangential flow filtration, annealing, distillation, lyophilization, and enzymatic ligation
• Troubleshooting and root cause analysis in a GMP production environment
• Understanding of drug substance development lifecycle from Tox through commercialization
• Experience with any of the following software packages: DeltaV (preferred), Rockwell, 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 and principles
• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented
• Guidance/mentoring of others through processes
• Flexibility to meet business needs