Senior Packaging Engineer (Hopewell, NJ)

Role: Senior Packaging Engineer within Manufacturing Science and Technology, focusing on life cycle validation and technical support for oral solid dose (OSD) packaging at the Hopewell, NJ site. Objectives: support technology transfer, equipment installation, start-up, and site readiness for Process Performance Qualification (PPQ) and Continued Process Verification (CPV). Responsibilities: serve as packaging SME, liaise with global engineering and artwork groups, manage Material Specifications and BOM, ensure regulatory compliance (GxP standards), oversee change controls, review batch records, develop validation and CPV protocols, support regulatory submissions, lead investigations, troubleshoot packaging processes, and support equipment initiatives. Requirements: Bachelor's degree with 4+ years engineering experience or Master’s with 2+ years, proficiency in Microsoft Office and ERP systems (SAP preferred). Familiarity with global pharmaceutical regulations (GMP, GDP) and experience leading cross-functional teams in biotech/pharma. Travel less than 10%. No direct reports but leads cross-functional teams. Preferred: experience in biotech/pharmaceutical industry, regulatory document authoring. High-value specifics include expertise in oral solid dose manufacturing, validation, regulatory compliance, and cross-functional collaboration to ensure product quality and patient safety.