Validation Technician

Company Information

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 and natural killer (NK) cell-based immunotherapy. 

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) in 2017. 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.

Legend Biotech is seeking Validation Technician, Aseptic Process as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

 The Process Validation Technician will support the validation department in establishing a robust and sustainable Aseptic Process Validation program through the life cycle of the program.

Key Responsibilities  

• Support validation engineers/scientists in drafting protocols and reports for all processes to be qualified/validated based on corporate/site guidelines, procedures, regulatory guidelines, and industry practices
• Strongly interface with Operations Department and other supporting groups (Engineering, Quality Control, Quality Assurance and other as applicable) to support the execution of validation activities.
• Assess process/equipment performance during qualification/validation studies in order to determine acceptability, reproducibility, and control.
• Support validation engineers/scientists in aseptic process validation, particle runs, container closure, filter integrity testing from protocol generation, training execution, oversite, and reporting standpoint.
• Support validation engineers/scientists in equipment process qualification and ensure consistency with process needs defined by Manufacturing or Tech Support.
• Support validation engineers/scientists in Continuous Process Verification (CPV) plan with coordination activities
• Provide backup support to the validation engineer/scientist during his/her absence.
• Assist management during internal and external regulatory audits (including FDA, EMEA)
• Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.

Requirements

• Bachelor’s degree in engineering or related field preferred.
• 3-5 years of operations experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.
• Ability to accommodate changes in the schedule including working on shift as necessary to support operational needs.
• Experience with start-up of new pharmaceutical manufacturing facilities preferred.
• Experience with performing sampling/testing and execution of validation studies.
• GMP manufacturing and/or validation experience is preferred.
• Maintain processes at a state of audit readiness and support internal and external inspections as required.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• 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.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Location of Role: Preference: Raritan, NJ
• Language Requirements: English
• Travel Requirements: Potentially up to 5%

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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.