Senior CQV Specialist

Legend Biotech is seeking a Senior CQV Specialist to join their Commissioning and Qualification team in Raritan, NJ. The Senior CQV Specialist will play a crucial role in providing Commissioning, Qualification, and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant.

This individual will handle day-to-day activities, including execution, protocol management, vendor management, and issue resolution. They will also address deviations, corrections, and remediation efforts for facility, equipment, systems, and processes, ensuring safe and compliant manufacturing operations in accordance with cGMP requirements.

This role requires CQV and engineering experience, the ability to work independently, and strong communication skills to collaborate with cross-functional groups. The goal is to establish a robust, compliant CQV program that enables the production, testing, and release of cell therapy 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 CAPA plans.
• Authors and executes CQV protocols, summary reports, and associated data.
• Participates in change controls, SOPs, and other documentation.
• Participates in authoring Risk Assessments, FMEAs, and other plans.

Requirements:

• Bachelor’s Degree in Science, Engineering, or equivalent.
• Minimum of 6 years of relevant work experience.
• Experience in an aseptic manufacturing facility, preferably cell therapy.
• Knowledge of cGMP regulations and FDA/EU guidance.
• Strong interpersonal and communication skills.
• Ability to process complex information and make critical decisions.
• Proficient in applying process excellence tools and methodologies.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
• Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols.
• Experience with TrackWise, CMMS and Maximo
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).

The role offers:

• Opportunity to work in a cGMP Clinical and Commercial Cell Therapy Manufacturing plant.
• Chance to contribute to personalized cell therapy production.
• Collaborative environment with cross-functional teams.