Principal Engineer – Visual Inspection

Eli Lilly and Company • Pleasant Prairie, WI

7d • $66,000 - $171,600 • Onsite

About The Position

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.

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.

Nice To Haves

• 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.

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: Automated Visual Inspection (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.
• 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 <790>, 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).
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior