Senior Packaging Engineer

Responsibilities

• Lead design, qualification, and troubleshooting of packaging equipment and processes (blister lines, cartoning, labeling, serialization, filling/capping lines)
• Own packaging validation lifecycle activities, including protocol authoring, execution, and approval for IQ/OQ/PQ studies
• Lead packaging technology transfer activities for new products, line changes, or site-to-site transfers
• Serve as packaging subject matter expert (SME) during internal audits and external regulatory inspections (FDA, ISO), including front room/back room support
• Author and approve packaging specifications, artwork/labeling requirements, and change control documentation
• Lead root cause investigations for packaging deviations, line rejects, and non-conformances, driving CAPA implementation
• Lead evaluation and implementation of new packaging equipment, materials, and technologies (e.g., serialization/track-and-trace systems, tamper-evident packaging)
• Partner with Manufacturing, Quality, Regulatory, and Supply Chain to ensure packaging designs meet regulatory, customer, and market requirements
• Drive continuous improvement initiatives to enhance line efficiency (OEE), reduce changeover time, and minimize packaging material waste
• Mentor and provide technical guidance to junior packaging engineers on equipment troubleshooting, validation, and documentation practices
• Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new packaging equipment and line installations
• Manage vendor and contractor relationships for packaging equipment suppliers and material vendors, ensuring quality and timeline adherence
• Support risk assessments (FMEA) for packaging process changes, new equipment, or material substitutions
• Ensure all packaging systems, equipment, and documentation comply with FDA regulations, cGMP, ISO 15378 (packaging materials), and internal quality standards
• Support compliance with serialization/track-and-trace regulations (e.g., DSCSA) as applicable to packaging lines

Qualifications

Required:

• Bachelor's degree in Engineering (Mechanical, Packaging, Industrial, Chemical, or related field)
• 5+ years of packaging engineering experience in pharmaceutical, biotech, or medical device manufacturing
• Strong hands-on experience with packaging equipment (blister, cartoning, labeling, serialization, filling/capping) and line troubleshooting
• Demonstrated experience leading validation of packaging equipment and processes (IQ/OQ/PQ)
• Strong working knowledge of cGMP, FDA regulations, and packaging-related compliance requirements (e.g., DSCSA/serialization)
• Experience supporting or leading FDA/regulatory inspections as a packaging SME
• Excellent written and verbal communication skills, with ability to influence cross-functional stakeholders and present to leadership
• Proven ability to manage multiple packaging projects simultaneously, including budgets, timelines, and vendor coordination
• Willingness to work on the production floor, including gowning/cleanroom protocols as required