CQV Specialist I

Job Description

Legend Biotech is seeking a CQV Specialist I to join their Technical Operations team in Raritan, NJ. This role is crucial for providing Commissioning, Qualification, and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. The CQV Specialist I will manage day-to-day activities, including execution, protocol management, vendor management, and handling issues, deviations, corrections, and remediation efforts for facility, equipment, systems, and processes. This supports safe and compliant manufacturing operations according to cGMP requirements.This role involves CQV and engineering experience, requiring the ability to work independently and drive effective communication across cross-functional groups. The goal is to establish a strong, compliant CQV program that enables robust production, testing, and release of products to patients.Responsibilities:

• Executes commissioning, qualification, requalification, validation, and maintenance activities.
• Manages multiple CQV projects, provides status reports, and coordinates with other departments or vendors.
• Supports technical and quality investigations, CAPAs, and corrections.
• Develops and performs remediation efforts and associated CAPA plans.
• Authors and executes CQV protocols, summary reports, and associated data.
• Participates in creating and revising change controls, SOPs, and other documentation.
• Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.
• Collaborates with Quality, Manufacturing Operations, Facilities & Engineering, Quality Control, Operations Technical Support, Supply Chain, and Planning.

Requirements:

• Bachelor’s Degree in Science, Engineering, or equivalent.
• Minimum of 2 years of relevant work experience.
• Experience in an aseptic manufacturing facility (preferably cell therapy), testing facility, quality assurance, or manufacturing compliance.
• Knowledge of cGMP regulations and FDA/EU guidance related to cell-based product manufacturing.
• Strong interpersonal and written/oral communication skills.
• Ability to process complex information and make critical decisions.
• Proficiency in process excellence tools and methodologies.
• Ability to independently manage a portfolio of ongoing projects.
• Attention to detail and adherence to procedures.
• Good written and verbal communication skills.
• Detailed knowledge of cGMP and cGTP related to CAR-T manufacturing or cell processing.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 (preferred: 600, 601, and 610).
• Experience authoring and executing documentation (Batch Records, SOPs, Work Instructions, CQV protocols).
• Experience with TrackWise, Comet, CMMS, Veeva, and Maximo.
• Proficiency with Microsoft Office applications.

Legend Biotech offers:

• Opportunity to work in cell therapy manufacturing.
• Collaborative team environment.
• Involvement in critical CQV activities.