Role OverviewThe 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 ResponsibilitiesProcess Ownership and Equipment Reliability- 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.
Technical LeadershipServe 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.
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).
Project Leadership- 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.
Mentorship and Development- 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.
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 InformationDay 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.
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). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in 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.
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