Asset Reliability Engineer

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 an Asset Reliability Engineer as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Asset / Reliability Engineer will be responsible for ensuring equipment/systems required to support an expanding Cell Therapy facility is appropriately purchased, qualified, deployed and maintained following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems engineering team. This role will require technical expertise and troubleshooting ability and shall drive effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients. This individual will be an integral part of the CAR-T Equipment team in support of ongoing clinical and commercial manufacturing as well as facility expansions and improvements.

Key Responsibilities

• Responsible for the technical support of all equipment and process support installations, focusing on preventing failures, increasing availability, and improving EHS & QUALITY compliance.
• Document proposals to reach solutions with relevant stakeholders (e.g., QA, C&Q, Operations) and develop root cause analyses in the context of Quality Investigations (QI's).
• Support CAPAs (Corrective and Preventive Actions) and CCs (Change Controls) within quality management systems, and write SOPs (Standard Operating Procedures) and work instructions that are part of the QMS (Quality Management System).
• Analyze the complete maintenance process using information from maintenance personnel, SAP, and technical documentation to convey outcomes to the Maintenance Manager.
• Monitor and evaluate the performance of the preventive maintenance plan and adjust as necessary based on changing operating conditions.
• Lead new projects and provide technical support for improvement projects of other departments, seeking new technologies/devices to optimize processes.
• Maintain close contact with suppliers of various devices and ensure correct SLA (Service License Agreement) is concluded.

• Bachelor’s Degree – Preferably in Engineering or Life Sciences
• Minimum 3 years of experience in Facility, Engineering, and/or Operations in a GMP production environment
• Experience in biotechnology or Cell Therapy preferred
• Experience managing others preferred
• Experience with managing utility and/or process equipment from specification development through full implementation in a GMP Commercial Facility
• Experience with Commissioning/Qualification, Asset Change Control, Process/System Improvement, Asset Lifecycle activities/documentation.
• Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
• Strong organizational skills.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional requirements and balance competing priorities effectively.
• Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment.
• Strong understanding of regulatory and compliance requirements
• Excellent oral and written communication skills; highly collaborative and inclusive
• Ability to effectively mentor and coach junior team members