Principal Engineer – Visual Inspection
Eli Lilly and Company
August 23, 2026
On-site
Pleasant Prairie, WI
Operations
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, ensuring automated/manual inspection operates safely, reliably, and in regulatory compliance.
Key Responsibilities
- Monitor and trend process performance, reject rates, and defect trends; use insights to drive decisions.
- Apply statistical tools (capability, control charts) to optimize parameters and reduce false reject rates while maintaining detection.
- Ensure AVI machines and manual inspection stations remain qualified and fit for intended use.
- Review/improve maintenance and calibration programs for inspection equipment.
- Support digital upgrades from a process engineering perspective.
- Serve as SME for AVI: machine qualification, recipe development/management, and performance monitoring.
- Train/mentor engineers; review/approve GMP/Responsible Engineer deliverables (e.g., SOPs, batch record changes, validation/change controls, inspection specs).
- Lead/support investigations, root cause analyses, and countermeasures for equipment deviations.
- Coordinate OEM relationships (service strategy, troubleshooting, spares, upgrades) and troubleshoot with global teams for continuous improvement.
- Support regulatory inspections/audits and compliance with GMP (including EU GMP Annex 1, USP, ASTM E2537); support inspection-process regulatory filings.
- Define project scope/deliverables; sponsor/manage inspection method validation and AVI qualification; evaluate/implement new platforms/vision upgrades.
Requirements
- Bachelor’s degree in Engineering/Pharmaceutical Sciences/related field.
- 12+ years senior engineering experience in parenteral/sterile drug product manufacturing.
- Strong knowledge of visual inspection principles, defect classification, and regulatory expectations for injectable drug products.
- Solid understanding of AVI and MVI for PFS products.
Preferred Qualifications
- Hands-on AVI platforms (e.g., Stevanato, Körber); recipe development; performance qualification/monitoring.
- Human factors and inspector qualification; CCI-related experience.
- IV/OV/PQ and inspection method validation; MES/CMMS/deviation-change systems (e.g., Veeva, SAP).
- Image analysis, lighting, and camera technologies.
Additional (Compensation/Benefits)
- Anticipated wage: $66,000–$171,600; bonus eligibility.
- Comprehensive benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.
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, ensuring automated/manual inspection operates safely, reliably, and in regulatory compliance.
Key Responsibilities
- Monitor and trend process performance, reject rates, and defect trends; use insights to drive decisions.
- Apply statistical tools (capability, control charts) to optimize parameters and reduce false reject rates while maintaining detection.
- Ensure AVI machines and manual inspection stations remain qualified and fit for intended use.
- Review/improve maintenance and calibration programs for inspection equipment.
- Support digital upgrades from a process engineering perspective.
- Serve as SME for AVI: machine qualification, recipe development/management, and performance monitoring.
- Train/mentor engineers; review/approve GMP/Responsible Engineer deliverables (e.g., SOPs, batch record changes, validation/change controls, inspection specs).
- Lead/support investigations, root cause analyses, and countermeasures for equipment deviations.
- Coordinate OEM relationships (service strategy, troubleshooting, spares, upgrades) and troubleshoot with global teams for continuous improvement.
- Support regulatory inspections/audits and compliance with GMP (including EU GMP Annex 1, USP, ASTM E2537); support inspection-process regulatory filings.
- Define project scope/deliverables; sponsor/manage inspection method validation and AVI qualification; evaluate/implement new platforms/vision upgrades.
Requirements
- Bachelor’s degree in Engineering/Pharmaceutical Sciences/related field.
- 12+ years senior engineering experience in parenteral/sterile drug product manufacturing.
- Strong knowledge of visual inspection principles, defect classification, and regulatory expectations for injectable drug products.
- Solid understanding of AVI and MVI for PFS products.
Preferred Qualifications
- Hands-on AVI platforms (e.g., Stevanato, Körber); recipe development; performance qualification/monitoring.
- Human factors and inspector qualification; CCI-related experience.
- IV/OV/PQ and inspection method validation; MES/CMMS/deviation-change systems (e.g., Veeva, SAP).
- Image analysis, lighting, and camera technologies.
Additional (Compensation/Benefits)
- Anticipated wage: $66,000–$171,600; bonus eligibility.
- Comprehensive benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.