Principal Engineer – Visual Inspection

Role: Principal Process Engineer – Visual Inspection at Lilly, focusing on ensuring the safety, reliability, and regulatory compliance of visual inspection processes for pre-filled syringes. Responsibilities include monitoring and optimizing automated and manual inspection systems (AVI and MVI), leading technical investigations, managing equipment qualification, and supporting digital upgrades. The role also involves regulatory review and inspection readiness, project leadership for process improvements and validation, and mentoring engineering staff. Requirements: Bachelor's in Engineering, Pharmaceutical Sciences, or related field; 12+ years' senior engineering experience in sterile drug manufacturing, with strong knowledge of visual inspection principles, defect classification, and regulatory expectations for injectables. Preferred qualifications include hands-on experience with AVI platforms (e.g., Körber, Stevanato), inspection recipe development, equipment qualification, and familiarity with MES, CMMS systems, and image analysis technology. High-value specifics: parenteral sterile products (PFS), regulated under EU GMP, USP standards; focus on automated visual inspection, equipment validation, process monitoring, and regulatory audits; occasional travel for technology transfers and supplier assessments. Location: day shift, with potential after-hours support. The role reports to site leadership and collaborates closely with global teams, manufacturing, quality, and supply chain units.