Validation Specialist
About The Position
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.
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
- 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
