Sr. Manager Engineering

Role: Senior Manager, Engineering supporting commercial CARVYKTI cell therapy manufacturing at Legend Biotech. Objectives: lead multidisciplinary engineering teams, optimize manufacturing equipment and processes, ensure operational reliability, and support continuous improvement initiatives to sustain quality and compliance. Responsibilities: oversee equipment lifecycle management, facilitate troubleshooting and investigations for manufacturing non-conformance, implement process enhancements, and lead CAPA and risk assessments. Collaborate with Manufacturing, Quality, Validation, and Supply Chain functions to maintain inspection readiness and regulatory compliance. Lead Facilities Investigation Team for deviation analysis and corrective actions. Qualifications: Bachelor's in Engineering (Chemical, Mechanical, Biomedical, etc.) with 10+ years in biopharma manufacturing, including 5+ years of leadership. Experience supporting cGMP biologics, cell therapy, or aseptic manufacturing is highly preferred. Skills: expertise in equipment lifecycle management, root cause analysis, process optimization, and regulatory standards (FDA, EMA, ICH). High-value biopharma details: focus on cell therapy, biologics, and advanced therapies; support for commercial manufacturing; and experience with validation, change control, and quality systems. Location: Raritan, NJ, with a focus on supporting ongoing manufacturing operations.