Validation Specialist
About The Position
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.
Requirements
- Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering or a related field.
- 2 years of experience in validation or manufacturing/process/production engineer within the pharmaceutical/biopharma industry.
- process validation, equipment qualification, or aseptic processing; writing or supporting Quality Risk Assessments.
Responsibilities
- 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 at Site.
- Support 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 escalate 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.
Benefits
- Medical, dental, and vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave after just three (3) months of employment
- Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
- 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
- Peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
