At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Organization Overview
For over 150 years, Lilly has manufactured medicines that improve lives worldwide. Lilly Manufacturing operates with rigorous quality standards and advanced technologies, with safety first and quality always as guiding principles.
Role Overview
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.
Key Responsibilities
Process Ownership and Equipment Reliability
- 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.
Technical Leadership
Serve as SME for:
- Formulation: bulk drug product formulation, bioburden control, sterile filtration, and formulation hold time management.
- 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). Note: primary packaging components (e.g., barrels, needle shields, backstops, plungers) are supplied ready-to-use (RTU) by the vendor.
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.
Regulatory and Audit Readiness
- 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).
Project Leadership
- 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.
Mentorship and Development
- 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.
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).
Preferred Qualifications
- 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.
Additional Information
Day shift with potential after-hours support during critical operations and/or investigations. Occasional travel may be required for technology transfers, regulatory interactions, or supplier assessments.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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