Sr. CQV Specialist

Role: Senior CQV Specialist supporting cGMP cell therapy manufacturing at Legend Biotech's Raritan, NJ facility, focusing on commissioning, qualification, validation, and remediation activities. Responsibilities: execute and manage CQV projects for facility, equipment, and systems; develop protocols, reports, and documentation ensuring compliance with cGMP, FDA, and EU regulations; lead investigations, CAPAs, and change controls; represent CQV during audits; and train junior team members. Requirements: Bachelor's in Science, Engineering, or related field; at least 7 years of relevant experience in aseptic, cell therapy, or biopharma manufacturing; strong knowledge of cGMP, GxP, and regulatory standards (FDA/EU); proficiency with CQV systems (e.g., Maximo, Siemens EMS); excellent communication and project management skills. Preferred: experience with CAR-T or cell processing manufacturing, ICH/21 CFR parts 210, 211, 1271, and authoring CQV documentation. HighValue: cell therapy, autologous/allogeneic modalities, CAR-T platform, cGMP compliance, validation, regulated audits. WorkSetup: onsite in Raritan, NJ, with responsibilities for day-to-day CQV execution and regulatory engagement.