Principal Engineer – Visual Inspection

Role Overview
Principal Process Engineer – Visual Inspection (PFS) is a technical leader and Subject Matter Expert for the visual inspection process of pre-filled syringes, ensuring safe, reliable, compliant automated and manual inspection.

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 machine parameters, reducing false rejects while maintaining detection.
- Ensure AVI machines and manual inspection stations remain qualified and fit for intended use.
- Review and improve maintenance and calibration programs.
- Support process engineering digital upgrades.
- Serve as SME for AVI: machine qualification, recipe development/management, and performance monitoring.
- Train/mentor engineers; review/approve Responsible Engineer and GMP documentation (as applicable).
- Lead/support investigations, root cause analyses, and countermeasures for equipment deviations.
- Manage OEM relationships (service, troubleshooting, spares, upgrades).
- Lead project scope/deliverables for capital and process improvements; sponsor/manage inspection method validation and AVI qualification.
- Lead evaluation/implementation of new inspection platforms/vision upgrades.
- Support regulatory inspections (FDA/EMA/etc.) and quality/HSE audits; support regulatory filings/responses.

Requirements
- BS in Engineering/Pharma Sciences or related technical field.
- 12+ years senior engineering experience in parenteral/sterile drug product manufacturing.
- Strong visual inspection principles, defect classification, and injectable drug regulatory knowledge.
- Solid understanding of AVI and MVI methodologies for PFS products.

Preferred Qualifications
- Hands-on AVI platforms (e.g., Stevanato, Körber); AVI recipe development and performance monitoring.
- Inspector qualification/human factors for MVI; CCI experience.
- IV/OV/PQ qualification and inspection method validation.
- MES/CMMS and deviation/change management (e.g., Veeva, SAP); image analysis, lighting, and camera technology.

Additional Information
- Day shift; potential after-hours support for critical operations/investigations/AVI recipe changes; occasional travel.

Compensation/Benefits (if applicable)
- Anticipated wage: $66,000–$171,600; eligible for company bonus and comprehensive benefits for eligible employees.

Application Instruction (accommodation)
- If you need accommodation to submit a resume, complete: https://careers.lilly.com/us/en/workplace-accommodation