CQV Specialist II

CQV Specialist II (Technical Operations)

Location:

Raritan, NJ

Legend Biotech is a global biotechnology company dedicated to treating life‑threatening diseases. Headquarters in Somerset, New Jersey, the company develops advanced cell therapies across several platforms, including CAR‑T, TCR‑T, and NK cell‑based immunotherapy.

This position will provide Commissioning, Qualification, and Validation (CQV) support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. The individual will handle day‑to‑day activities such as protocol management, vendor management, issue resolution, deviations, corrections, and remediation efforts for facility, equipment, systems, and processes, ensuring safe and compliant manufacturing operations according to cGMP requirements.

• Execute commissioning, qualification, requalification, validation, and associated maintenance activities within the plant.
• Manage multiple, complex CQV projects; provide status reports and coordinate with cross‑functional departments or external contractors/vendors.
• Own and support technical and quality investigations, CAPAs, and corrections.
• Develop and perform remediation efforts and associated CAPA plans.
• Author, own, and execute master and completed CQV protocols, summary reports, and associated data to meet regulatory, SOP, specification, and data integrity requirements.
• Execute, own, assess, and participate in 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.
• Collaborate with Quality, Manufacturing Operations, Facilities & Engineering, Quality Control, Operations Technical Support, Supply Chain, and Planning teams.

• Bachelor’s Degree in Science, Engineering, or equivalent technical discipline.
• Minimum 4 years of relevant work experience, preferably in aseptic manufacturing, cell therapy, testing facility, quality assurance, or manufacturing compliance.
• Knowledge of cGMP regulations and FDA/EU guidance for cell‑based product manufacturing, including Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to process complex information quickly and make critical decisions with limited data.
• Proficiency in applying process excellence tools and methodologies.
• Independent responsibility for a portfolio of ongoing projects.
• Attention to detail and adherence to procedures.
• High organization and teamwork under supervision.
• Detailed knowledge of cGMP and cGTP related to CAR‑T manufacturing or cell processing.
• Ability to identify and remediate gaps in processes or systems.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 (required); 600, 601, 610 (preferred).
• Experience authoring and executing documentation (Batch Records, SOPs, Work Instructions, CQV protocols).
• Experience with Track Wise, CMMS, and Maximo.
• Proficiency with Microsoft Office (Outlook, Excel, Word, PowerPoint).
• Language:
  English.

$81,273 – $106,669 USD per year.

Legend Biotech offers a comprehensive benefits package for permanent employees, including medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity and stock options; eight weeks paid parental leave; paid time off (vacation, personal, sick, 11 company holidays, 3 floating holidays); flexible spending and health savings accounts; life and AD&D; short‑ and long‑term disability; legal assistance; supplemental plans;

commuter benefits; family planning and care resources; well‑being initiatives; and peer‑to‑peer recognition programs. Contract employees are not eligible for benefits.

Legend Biotech provides equal employment opportunities regardless of race, color, creed, religion, national origin, ancestry, citizenship, age, sex, gender identity, sexual orientation, marital status, military service, disability, genetic information, or any other characteristic protected by law. Employment is at‑will and may be terminated with or without cause. Legend Biotech maintains a drug‑free workplace.