Engineer – Inspection and Packaging

Overview We are seeking a highly experienced and detail-oriented Inspection and Packaging Engineer to join our Sterile Drug Product Engineering team. The Inspection and Packaging Engineer will be a key member of the Engineering Department and serve as the primary equipment Subject Matter Expert (SME) for parental drug visual inspection and secondary packaging equipment. This role will be responsible for providing technical and engineering support throughout the equipment lifecycle, including design review, vendor coordination, FAT/SAT, commissioning, qualification support, start-up, troubleshooting, and ongoing performance improvement.

The ideal candidate will have strong hands-on experience with manual inspection, automatic inspection, labeling and packaging. The Engineer will work closely with Manufacturing, Technical Services, Validation, Quality, and external equipment vendors to ensure equipment is designed, installed, qualified, and operated in a reliable and compliant manner.

This is an individual contributor position with no direct reports.

Responsibilities Technical Oversight Serve as the primary equipment SME for visual inspection and secondary packaging systems, including manual visual inspection, automated visual inspection (AVI), labeling machines, assembling machines, packaging machines, cartoners, case packers, and associated packaging systems.

Provide engineering and technical support throughout the equipment lifecycle, including equipment selection, design review, FAT, SAT, installation, commissioning, IQ, OQ, PQ, and applicable system qualification and performance testing.

Develop and maintain in-depth knowledge of visual inspection technologies, including inspection principles, defects development and management, and inspection system performance. Support development and qualification of inspection defect libraries and representative defect samples for manual and automated visual inspection systems.

Lead technical troubleshooting and root cause analysis for inspection and packaging equipment failures, performance issues, false rejects, missed defects, labeling issues, and recurring equipment problems, and support implementation of effective corrective actions.

Driving equipment reliability, inspection performance, line efficiency, preventive maintenance improvement, and continuous improvement initiatives in collaboration with Manufacturing and Maintenance.

Support product technology transfer, scale-up, and new product introduction activities by ensuring inspection and packaging equipment is capable of meeting product-specific requirements.

Act as the technical owner for equipment maintenance procedures, spare parts management strategy, inspection system performance monitoring, and future equipment modifications or upgrades, while maintaining equipment in a qualified and controlled state.

Regulatory Compliance Ensure assigned inspection and packaging equipment and engineering activities are executed in compliance with cGMP requirements, applicable regulatory expectations (PDA TRs, USP 790, 1790), and internal quality and engineering standards.

Support regulatory inspections, customer audits, and internal audits by serving as the equipment SME for visual inspection and packaging systems.

Partner with Quality Assurance and Validation to maintain the validated state and continuous compliance of inspection and packaging systems.

Support deviation investigations, CAPA implementation, change control assessments, and technical impact evaluations related to visual inspection and packaging equipment.

Cross-Functional Collaboration and Technical Support Work closely with Operations and Technical Services teams to support equipment readiness, process implementation, technology transfer,…