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 #J-18808-Ljbffr