Validation Specialist

Company

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Validation Specialist

Execute site validation activities to the current regulatory and site requirements and address deviations associated with those activities including oversight of pre‑validation and validation activities resulting from technical changes. Control aseptic process validation and particular runs from protocol generation, training execution oversight 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 elevate 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 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

Benefits and Paid Time Off:
Medical, dental, and vision insurance; 401(k) retirement plan with company match that vests fully on day one; 8 weeks paid parental leave after three months of employment; paid time off including vacation, personal, sick, floating holidays, and eleven company holidays. Other types of pay: performance‑based bonus and/or equity in eligible roles. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance;

voluntary commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs.

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.