Senior Parenteral Formulation & Aseptic Process Engineer

Eli Lilly and Company; Wisconsin; On-site; USD 66,000 - 172,000; Full time

Job summary

Lilly is seeking a Principal Process Engineer – Formulation & Component Preparation to act as SME for sterile drug product formulation and component preparation that support pre-filled syringe and vial manufacturing. This role ensures compounding, filtration, and component processing operations are performed safely, efficiently, and in full GMP compliance.

You will lead process ownership, guide and mentor engineers, review GMP documentation, and partner with global teams to implement best

Qualifications

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related Engineering field.
• 8+ years of senior engineering experience in parenteral or sterile drug product manufacturing.
• Strong knowledge of aseptic formulation processes and GMP requirements.
• Solid understanding of component preparation in support of PFS manufacturing (washing and steam sterilization).

Responsibilities

• Monitor and trend process performance to support day-to-day decision making in formulation and component preparation.
• Apply statistical tools 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.
• 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.

Skills

Process engineering

Statistical tools

GMP knowledge

Aseptic formulation

Education

Bachelor’s degree in Chemical Engineering

Bachelor’s degree in Pharmaceutical Sciences

Bachelor’s degree in Chemistry

Tools

MES

CMMS

Veeva

SAP

IQ/OQ/PQ

Job description

Lilly is seeking a Principal Process Engineer – Formulation & Component Preparation to act as SME for sterile drug product formulation and component preparation that support pre-filled syringe and vial manufacturing. This role ensures compounding, filtration, and component processing operations are performed safely, efficiently, and in full GMP compliance.

You will lead process ownership, guide and mentor engineers, review GMP documentation, and partner with global teams to implement best