Principal Engineer - Formulation & Component Prep

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 (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 implementation of key digital upgrades and initiatives from a process engineering perspective ensuring they meet process needs. Technical Leadership Serve as SME for formulation and component preparation. Includes bulk drug product formulation, bioburden control, sterile filtration, formulation hold time management, washing and steam sterilization of process equipment and consumables introduced into the aseptic environment. 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 such as 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 OEM relationships critical to equipment reliability (service strategy, troubleshooting, spares, upgrades). Work closely with global engineering team and other site engineers to ensure best practices, procedures, and processes are being implemented at the site. Regulatory and Audit Readiness Serve as a technical SME during regulatory inspections (FDA, EMA) and internal quality and HSE audits for formulation and component preparation. Ensure ongoing compliance with applicable regulations and standards (21 CFR Part 211, EU GMP Annex 1, 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. Manage validation lifecycle activities, including cleaning validation, washer cycle development, and autoclave cycle development/qualification for process equipment and isolator consumables. 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 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 (Fedegari, STERIS). Experience with formulation skid and filtration system operation and validation (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 (Veeva, SAP). Knowledge of subvisible particle testing standards (USP) 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. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( 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. Compensation & Benefits 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). 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 such as 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 such as employee assistance program, fitness benefits, and employee clubs and activities. EEO Statement 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. 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