Director, Aseptic DP Process Engineering

Role: Director of Aseptic Drug Product Process Engineering for a new biotherapeutics manufacturing facility at Johnson & Johnson, leading end-to-end process design and operational readiness. Responsibilities: develop process specifications, assess vendor capabilities, troubleshoot during commissioning, coordinate across manufacturing, facilities, quality, and engineering teams, and ensure compliance with cGMP, EHS, and regulatory standards (EU, FDA). Drive project execution, technical excellence, and team development, with a focus on facility design, process validation, and continuous improvement. Qualifications: minimum of a Bachelor's in Mechanical or Chemical Engineering, 15+ years in biotherapeutic drug product process engineering within a cGMP environment, with at least 5 years in leadership roles. Experience in capital projects (preferably $250-500M), greenfield site development, and facility start-up. Deep knowledge of aseptic manufacturing standards, EU Annex 1, and regulatory requirements. Skills include project management, vendor assessment, complex problem-solving, and cross-functional collaboration. High-value specifics: biologics, biotherapeutics, cGMP, aseptic manufacturing, facility design, commissioning & qualification, regulatory compliance, and international standards. Location: Wilson, North Carolina, with >75% travel during project development.