Job Abstract

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 Maintenance Support Specialist as part of the Facilities and Engineering team based in Raritan, NJ.

Role Overview

This position will be responsible for maintenance support, reviewing documents, supporting investigations, vendor reports, and work orders for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state-of-the-art cell therapy facility for commercial launch and sustained production. The role will require proven leadership and expertise that drives effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Key Responsibilities

• Assisting in Scheduling, planning, and organizing maintenance activities with all department owners and specialists performing work.
• Assist in document updates and quality investigations.
• Manages archiving of department documents, reviewing logbooks, vendor reports and work orders.
• Reviewing of Work orders and vendor documents to ensure GXP and quality compliance.
• Maintain vendor training records, schedule vendor trainings.
• Maintain facility cleaners trainings and logbooks.
• Identifies and surveys new equipment for asset creation in CMMS.
• Possesses a general functional, mechanical and technical understanding of facility, equipment and utilities.
• Handles a variety of facilities & engineering department administrative support activities.
• Supports facility project initiatives as needed which includes engineering, maintenance and validation projects.
• Track and maintain standards and calibration certificates.
• Supports department in creation and tracking of PO’s.
• Supports maintenance driven quality events including but not limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA’s.
• Ensures regulatory and job training remains current by promptly completing required training.
• Complies with all company and/or site policies and procedures.
• Demonstrates willingness to learn new skills as required.
• Available for other duties as required.
• Ensures site compliance with all local, state and federal regulations including and equivalent to Federal.
• Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Drug Enforcement Agency (DEA) as applicable (TSA) Transportation Security Administration.
• Ability to work independently and with minimal guidance/oversight.

• B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field or minimum of a High School diploma required with equivalent experience.
• Minimally 5+ years of experience in an industrial manufacturing or regulated environment is required, ideally has cGMP cleanroom manufacturing experience under aseptic conditions.
• Experience with CMMS or similar maintenance management system is required.
• Experience in document review required.
• Proficiency in more than one craft.
• Experience in the Pharmaceuticals or related industry is preferred.
• Experience with cGMP manufacturing.
• Experience working in a controlled, cleanroom environment under aseptic conditions is preferred.
• Experience in HVAC and cleanroom maintenance is preferred.
• Proficiency in English (verbal and written) and strong communication skills.

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.