CQV Specialist

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Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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 R&D 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, a pharmaceutical company of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership combines the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech seeks a CQV Specialist I as part of the Technical Operations team based in Raritan, NJ.

This position will be responsible for providing Commissioning, Qualification, and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. The individual will handle day‑to‑day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections, and remediation efforts 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 requires CQV and engineering experience, the ability to work independently, and strong communication, coordination, and collaboration across cross‑functional groups to establish a strong, compliant CQV program that enables robust production, testing, and release of product to patients.

• Executes the commissioning, qualification, re‑qualification, validation and associated maintenance activities within the plant
• Manages multiple and complex CQV projects, 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 required remediation efforts and associated CAPA plans
• Authors, owns, and executes master and completed 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 reviews
• Works in a collaborative team setting with Quality, Manufacturing Operations, Facilities & Engineering, Quality Control, Operations Technical Support, Supply Chain, and Planning

• A bachelor’s degree in Science, Engineering, or an equivalent technical discipline
• At least 2 years of relevant work experience, preferably in an aseptic manufacturing facility, cell therapy, testing facility, quality assurance, or manufacturing compliance
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products, as well as Good Tissue Practices
• Strong interpersonal and written/in‑oral communication skills
• Ability to quickly process complex information and make critical decisions with limited information
• Proficient in applying process excellence tools and methodologies
• Ability to independently manage a portfolio of ongoing projects
• Attention to detail and adherence to procedures
• Highly organized and capable of working in a team environment with a positive attitude under some supervision
• Good written and verbal communication skills
• Ability to summarize and present results, and experience with team‑based collaborations
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR‑T manufacturing…