Sr. CSV/CQV Specialist

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking a Sr. CSV/CQV Specialist as part of the Manufacturing & Supply team based in Raritan, NJ. Role Overview This position will be responsible for providing Commissioning, Qualification and Validation support to all computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts of computerized systems for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CSV and engineering experience, ownership and leadership, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CSV program to enable robust production, testing and release of product to patients. Key Responsibilities Acts as the subject matter expert (SME) for 21 CFR Parts 210, 211, 11, EU Annex 11 among others. Works with above plant center of excellence (COE) to successful implement and maintain tools, standards, policies and procedures in compliance. Executes the commissioning, qualification, requalification, validation and any associated activities within the plant of all computerized systems such as SAP, MES, manufacturing and laboratory equipment, BAS, EDS and other software and systems. Manages multiple and complex CSV projects in accordance with CQV, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks. Supports and/or owns technical and quality investigations, CAPAs and corrections. Develops and performs any required remediation efforts and associated CAPA plans. Authors, owns and executes master and completed CSV/CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity. Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation. Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Review. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Requirements A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required. A minimum of 8 years relevant work experience is required with expertise in 21 CFR Part 11, 58, 210 and 211, Eudralex regulations and ICH guidelines. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or…