Principal Engineer - Visual Inspection

Organization Overview Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, with a history of 150 years manufacturing medicines that improve lives worldwide. The Manufacturing organization operates with rigorous quality standards, advanced technologies, safety first, and quality always as guiding principles. Role Overview The Principal Process Engineer – Visual Inspection (PFS) serves as a technical leader and Subject Matter Expert for the visual inspection process of pre‑filled syringes. This role ensures that both automated and manual inspection processes operate safely, reliably, and in full compliance with regulatory requirements. Key Responsibilities Monitor and trend process performance, reject rates, and defect trends, and leverage insights to drive operational decisions. Apply statistical tools (e.g., capability, control charts) to understand process variability, optimize machine parameters, and reduce false reject rates while maintaining detection capability. Ensure all inspection systems—automated visual inspection (AVI) machines and manual inspection stations—remain in a qualified state and fit for intended use. Review and improve maintenance and calibration programs for inspection equipment. Support implementing key digital upgrades and initiatives from a process engineering perspective ensuring they meet the process needs. Serve as Subject Matter Expert for AVI: machine qualification, recipe development and management, and ongoing performance monitoring. Train and mentor engineers in data analysis, problem‑solving, inspection system design, and execution excellence. Review and approve documentation requiring Responsible Engineer deliverables and GMP documentation, as applicable (e.g., SOPs, batch record changes, validation protocols/reports, change controls, inspection specifications). Lead or support investigations, root cause analyses, and countermeasure implementation for equipment‑related deviations. 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 team, other site engineers (both inspection and filling), and material team to troubleshoot issues and drive the process towards continuous improvement. Support preparing and reviewing regulatory filings and responses related to inspection processes (inspection method descriptions, validation summaries, responses to agency queries). Define project scope, user requirements, and technical deliverables for capital projects and process improvement initiatives related to inspection technologies and workflows. Sponsor and manage inspection method validation and AVI qualification activities. Lead evaluation and implementation of new inspection platforms or vision system upgrades. Coach and mentor junior and mid‑level engineers in visual inspection science and technology. Promote standardization of inspection procedures, defect classification, and documentation quality across shifts and product lines. Support development of training materials and qualification programs for inspectors and cross‑functional teams. Regulatory and Audit Readiness Serve as a key technical contact during regulatory inspections (FDA, EMA, etc.) and internal quality/HSE audits for visual inspection operations. Ensure ongoing compliance with applicable GMP regulations and standards, including EU GMP Annex 1, USP, and ASTM E2537. Support preparation and review of regulatory filings and responses related to inspection processes (inspection method descriptions, validation summaries, responses to agency queries). Requirements Bachelor’s degree in Engineering, Pharmaceutical Sciences, or a related technical field. 12+ years of senior engineering experience in parenteral or sterile drug product manufacturing. Strong knowledge of visual inspection principles, defect classification, and regulatory expectations for injectable drug products. Solid understanding of both AVI and MVI methodologies as applied to PFS products. Preferred Qualifications Hands‑on experience with AVI platforms (e.g., Stevanato, Körber). Experience with AVI recipe development, machine performance qualification, and ongoing process performance monitoring. Familiarity with inspector qualification programs and human factors methodologies for MVI. Experience with container closure integrity (CCI) as it relates to inspection processes. Equipment qualification (IV/OV/PQ) and inspection method validation experience. Experience with MES, CMMS, and deviation/change management systems (e.g., Veeva, SAP). Knowledge of image analysis, lighting systems, and camera technologies as applied to pharmaceutical inspection. Additional Information Day shift with potential after‑hours support during critical operations, investigations, or AVI recipe changes. Occasional travel may be required for technology transfers, regulatory interactions, or equipment supplier assessments. EEO and Accommodation Lilly is a proud 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. 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 ( 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 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 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. Employee Resource Groups Lilly’s employee resource groups (ERGs) offer support networks for members and are open to all employees. 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), and enAble (for people with disabilities). Learn more about all of our groups. Fair Hiring Statement Lilly is dedicated to open and inclusive hiring practices. If you require an accommodation for any part of this application process, please let us know. Lilly does not discriminate based on protected characteristics in hiring decisions. #J-18808-Ljbffr BioSpace