Sr. CSV/CQV Specialist

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases.

About the role

This position will provide Commissioning, Qualification and Validation (CSV/CQV) support to all computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant in Raritan, NJ. The Sr. CSV/CQV Specialist will handle day-to-day activities including execution, protocol management, vendor management, issues, deviations, corrections, and remediation efforts for computerized systems supporting personalized cell therapy production. This role requires CSV and engineering experience, leadership, and the ability to work independently while collaborating across cross-functional groups to establish a compliant CSV program.

Responsibilities

• Act as the subject matter expert (SME) for 21 CFR Parts 210, 211, 11, EU Annex 11, and other relevant regulations.
• Work with the plant center of excellence (COE) to implement and maintain compliant tools, standards, policies, and procedures.
• Execute commissioning, qualification, requalification, validation, and associated activities for computerized systems such as SAP, MES, manufacturing and laboratory equipment, BAS, EDS, and other software/systems.
• Manage multiple and complex CSV projects, provide status reports, and coordinate with departments or external contractors/vendors.
• Support or own technical and quality investigations, CAPAs, and corrections.
• Develop and perform remediation efforts and associated CAPA plans.
• Author, own, and execute master and completed CSV/CQV protocols, summary reports, and associated data to ensure compliance with regulations, SOPs, and specifications, with a focus on data integrity.
• Execute, own, assess, and participate in the creation, revision, and review of change controls, SOPs, and other documentation.
• Participate in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.
• Perform job duties that routinely require exposure to and handling of biological materials and hazardous chemicals.

Requirements

• A minimum of a Bachelor’s Degree in Science, Engineering, or an equivalent technical discipline.
• At least 8 years of relevant work experience with expertise in 21 CFR Part 11, 58, 210, 211, Eudralex regulations, and ICH guidelines.
• Experience working in an aseptic manufacturing facility, preferably in cell therapy, testing, quality assurance, or manufacturing compliance.
• Expertise in GMP compliance, including 21 CFR Part 11 and EU Annex 11.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 (preferred: 600, 601, and 610).
• Thorough knowledge of GMP data integrity standards and FDA/EU guidance related to cell-based product manufacturing, including Good Tissue Practices (cGTP).
• Strong interpersonal, written, and oral communication skills.
• Ability to process complex information and make critical decisions with limited information.
• Proficiency in applying process excellence tools and methodologies.
• Ability to independently manage a portfolio of ongoing projects.
• Highly organized, detail-oriented, and capable of working in a team environment with minimal supervision.
• Experience authoring and executing documentation such as Batch Records, SOPs, Work Instructions, and protocols.
• Experience with TrackWise, CMMS, and Maximo.
• Proficient in Microsoft Office applications (Outlook, Excel, Word, PowerPoint).

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off policy including vacation, personal time, sick time, floating holidays, and eleven company holidays.
• Flexible spending and health savings accounts.
• Life and AD&D insurance, short- and long-term disability coverage.
• Legal assistance and supplemental plans (e.g., pet, critical illness, accident, hospital indemnity insurance).
• Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

Pay

Base pay range: $110,706 – $145,303 USD. Performance-based bonus and/or equity may be available for eligible roles.