OverviewWe are seeking a highly experienced and detail-oriented
Inspection and PackagingEngineer 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.
ResponsibilitiesTechnical 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, and new product introduction activities.
- Partner with Validation and Quality to provide engineering expertise for qualification, validation, deviation investigations, and compliance-related activities.
- Support development and execution of operator and technical training.
- Act as a key technical interface between internal departments and equipment vendors to support efficient issue resolution and long-term equipment performance.
QualificationsRequired Qualifications: - Excellent written and verbal communication skills, with attention to detail and clarity.
- Bachelor's or master's degree in engineering, Life Sciences, or a related technical discipline.
- Minimum of 8 years of experience in the pharmaceutical or biotechnology industry.
- Hands-on experience with visual inspection systems for pharmaceutical products, including manual visual inspection and/or automated visual inspection (AVI).
- Experience with secondary packaging equipment, including labeling machines, assembling machines, cartoners, case packers, and associated packaging systems is strongly preferred.
- Deep understanding of cGMP requirements, risk-based approaches, and global regulatory expectations.
- Proven experience in start-up or expansion of manufacturing facilities is highly preferred.
- Strong knowledge of current Good Manufacturing Practices (cGMP), regulatory guidelines (FDA, EMA, ICH), and industry standards.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
