Validation 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.

From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech USA, Inc

Validation Specialist

Execute site validation activities to the current regulatory and site requirements and address deviations associated with those activities including oversite of pre-validation and validation activities resulting from technical changes. Control Aseptic process validation and particle runs from protocol generation, training execution oversite and reporting. Support equipment process qualification and ensure consistency with process needs defined by Manufacturing or Tech Support. Support the investigation of validation/PQ/study challenges port the establishment of KPI and own execution of routing CPV/OPV reporting.

Support APQ/APQR site reporting with data analysis and evaluation. Provide technical assessments, rationales, and approval for engineering and process changes to meet regulatory requirements. Implement and evaluate raw material and consumable changes for process impact including but not limited to leachable/extractable studies and perform associated implementation studies. Implement packaging and labeling changes including related studies and validation activities. Oversee the manufacturing visual inspection program.

Control the manufacturing control strategy and microbial control strategy. Assess change controls for validation impact. Establish key stakeholder relationships with internal and external stakeholders. Identify and escalation potential risk areas/shortfalls to ensure the process remains in a validated state. Work cross-functionally across Technical Operations and interface with external vendors to drive the design and implementation of automation platforms for cell therapy development and manufacturing.

• Education Required:
  
  Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering or a related field.
• Experience
  
  Required:
  
  2 years of experience in validation or manufacturing/process/production engineer within the pharmaceutical/biopharma industry.
• Special
  
  Skills Required:
  
  process validation, equipment qualification, or aseptic processing; writing or supporting Quality Risk Assessments.

1000 US-202, Raritan, NJ 08869.

9:00 a.m. to 5:00 p.m. 5 days 40 hr/wk

$120,000 per year

Performance-based bonus and/or equity is available to employees in eligible roles.

Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal…