Principal Engineer – Formulation & Component Prep

Eli Lilly and Company • Pleasant Prairie, WI

2d • Onsite

About The Position

The Principal Process Engineer – Formulation & Component Preparation (Parenteral/Aseptic Fill & Finish) is a technical leader and Subject Matter Expert (SME) for sterile drug product formulation and component preparation activities that support pre-filled syringe (PFS) and vial manufacturing. The role ensures compounding, filtration, and component processing operations are executed safely, efficiently, and in full compliance with current GMP and regulatory requirements.

Requirements

• Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related Engineering field.
• 8+ years of senior engineering experience in parenteral or sterile drug product manufacturing.
• Strong knowledge of aseptic formulation processes (bulk drug product formulation, sterile filtration, bioburden control) and GMP requirements.
• Solid understanding of component preparation in support of PFS manufacturing (washing and steam sterilization of process equipment and consumables introduced into the aseptic environment).

Nice To Haves

• Experience with parenteral component washing systems (e.g., Fedegari, STERIS).
• Experience with formulation skid and filtration system operation and validation (e.g., Tecninox).
• Familiarity with gamma-irradiated component supply chains and associated supplier quality management.
• Familiarity with extractables/leachables concepts for PFS and vial systems.
• Experience with equipment qualification (IQ/OQ/PQ) and process validation.
• Experience with MES, CMMS, and deviation/change management systems (e.g., Veeva, SAP).
• Knowledge of subvisible particle testing standards (USP <787>/<788>) and their relationship to formulation and component quality.

Responsibilities

• Monitor and trend process performance to support day-to-day decision making in formulation and component preparation.
• Apply statistical tools (e.g., capability, control charts) to quantify variability, identify drivers, and prioritize continuous improvement.
• Ensure formulation skids, filtration assemblies, washers, and autoclaves remain qualified/validated and fit for intended use (including periodic review and requalification, as applicable).
• Partner with Maintenance/Calibration to review and improve preventive maintenance and calibration strategies for relevant assets.
• Support implementing key digital upgrades and initiatives from a process engineering perspective ensuring it meets the process needs.
• Serve as SME for: Formulation: bulk drug product formulation, bioburden control, sterile filtration, and formulation hold time management.
• Serve as SME for: Component Preparation: washing and steam sterilization (autoclave) of process equipment and consumables introduced into the aseptic/isolator environment (e.g., machine parts, formulation load items, canisters, and transfer kits).
• Guide, train, and mentor engineers in data analysis, problem-solving, root cause analysis, process design, and execution excellence.
• Review and approve (as Responsible Engineer) engineering deliverables and GMP documentation, as applicable (e.g., SOPs, batch record changes, validation protocols/reports, and change controls).
• Lead and/or support deviations and investigations, including root cause analysis and implementation of effective corrective and preventive actions (CAPA) for formulation and component preparation processes.
• Manage and coordinate original equipment manufacturer (OEM) relationships critical to formulation and component preparation equipment reliability (e.g., service strategy, troubleshooting, spares, upgrades).
• Work closely with global engineering team and other site engineers to ensure that best practices, procedures and processes are being implemented at the site.
• Serve as a technical SME during regulatory inspections (e.g., FDA, EMA) and during internal quality and HSE audits for formulation and component preparation.
• Ensure ongoing compliance with applicable regulations and standards (e.g., 21 CFR Part 211, EU GMP Annex 1, and relevant pharmacopeial requirements such as USP/EP for particulates).
• Support preparation and review of regulatory filings and responses (process descriptions, validation summaries, responses to agency queries).
• Define project scope, user requirements, and technical deliverables for capital projects, technology transfers, and process improvement initiatives.
• Sponsor and manage validation lifecycle activities, including cleaning validation, washer cycle development, and autoclave cycle development/qualification for process equipment and isolator consumables (as applicable).
• Lead implementation of new formulation technologies or component preparation equipment.
• Coach and mentor junior and mid-level engineers across formulation and component preparation disciplines.
• Promote standardization of procedures, best practices, and documentation quality.
• Support development of training materials and qualification programs for cross-functional teams.

Benefits

• company bonus
• company-sponsored 401(k)
• pension
• vacation benefits
• medical benefits
• dental benefits
• vision benefits
• prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance
• 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: Principal