Sr. QA Validation Specialist, CSV & Equipment

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three RD sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. QA Validation Specialist, CSV Equipment as part of the Quality team based in Raritan, NJ . Role Overview The Sr. QA Validation Specialist, CSV Equipment role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping validation, and data integrity. Key Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the site Review and approve qualification/validation documentation (specifications, protocols, reports). Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration). Provide expertise and solutions to issues regarding qualification and validation strategies and documentation. Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for all site systems. Assist in the development of validation and qualification related policies, procedures, templates, forms. Provides quality oversight on data integrity of systems, instruments, and equipment used at the site. Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations. Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan Site. Review and approve change controls, SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ensure effectiveness of related actions. Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. Drive continuous improvement. Provide training and guidance to other members of the team. Other duties may be assigned, as necessary. Requirements A minimum of a Bachelor’s Degree in Science or equivalent technical discipline is required. 7+ years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Knowledge of cGMP regulations and FDA/EU guidance related to GMP manu ... (truncated, view full listing at source)