Engineer – Inspection and Packaging

Location: Middletown, Delaware, United States. On-site position.

Company

hirify.global's Sterile Drug Product Engineering team supports inspection and secondary packaging equipment for pharmaceutical manufacturing.

What you will do

• Serve as the primary equipment subject matter expert for manual and automated visual inspection, labeling, cartoning, case packing, and related packaging systems.
• Provide engineering support across equipment selection, design review, FAT, SAT, installation, commissioning, IQ, OQ, PQ, qualification, start-up, and ongoing performance improvement.
• Develop inspection defect libraries and representative samples, and monitor inspection system performance.
• Lead troubleshooting and root cause analysis for equipment failures, false rejects, missed defects, labeling issues, and recurring performance problems.
• Support technology transfer, scale-up, new product introduction, equipment reliability, preventive maintenance, and continuous improvement initiatives.
• Coordinate with Manufacturing, Technical Services, Validation, Quality, Maintenance, and external equipment vendors.

Requirements

• 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 manual visual inspection and/or automated visual inspection systems for pharmaceutical products.
• Strong knowledge of cGMP requirements, risk-based approaches, FDA, EMA, ICH, PDA, and USP 790/1790 expectations.
• Experience with secondary packaging equipment, including labeling machines, assembling machines, cartoners, case packers, and related systems.
• Strong written and verbal communication skills with attention to detail.

Nice to have

• Experience with start-up or expansion of manufacturing facilities.

Culture & Benefits

• Individual contributor position with no direct reports.
• Cross-functional collaboration with Operations, Manufacturing, Technical Services, Validation, Quality, Maintenance, and equipment vendors.
• Opportunity to support operator and technical training, regulatory inspections, customer audits, deviation investigations, CAPA, and change controls.