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.

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.

• 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.

• 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).

• 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.

• Hands‑on experience with AVI platforms (e.g.,…