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 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 on-going clinical and commercial manufacturing as well as facility expansions and improvements.
Key Responsibilities
- As an Asset / Reliability Engineer you are responsible for the technical support of all equipment and process support installations. A solid maintenance plan forms the basis to make the performance and behavior of the equipment more reliable. The focus will often be on preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the proper functioning of the equipment and takes actions to optimize the output, reliability, quality, performance. He/she makes proposals for Continuous improvement and gets to work on this.
- As an Asset / Reliability Engineer you are responsible for the technical support of all equipment and process support installations. A solid maintenance plan forms the basis to make the performance and behavior of the equipment more reliable. The focus will often be on preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the proper functioning of the equipment and takes actions to optimize the output, reliability, quality, performance. He/she makes proposals for Continuous improvement and gets to work on this.
- You have strong knowledge of cGMP requirements. You document proposals to reach a solution with relevant stakeholders (e.g. QA, C&Q, Operations, ... ). You will develop root cause analyses in the context of Quality Investigations (QI's). He/she supports CAPAs (Corrective and Preventive Actions) and CCs (Change Controls) within quality management systems. You will also write SOPs (Standard Operating Procedures) and work instructions that are part of the QMS (Quality Management System).
- You combine the knowledge of the employees in the maintenance process, the information from SAP, the technical documentation and other data systems. With this information, the Asset / Reliability Engineer can perform analyses on the complete maintenance process. The outcome of this analysis can be conveyed to the Maintenance Manager in a structured way so that he can set the right priorities.
- After implementation of the maintenance plan, the Asset / Reliability Engineer monitors and evaluates the performance of the preventive maintenance plan. In the event of changing operating conditions, you take action to adjust the maintenance plans. You monitor the status of the maintenance checklists and calibration records. You follow up the technical works on the basis of an asset management system.
- You take the lead in new projects and also provide technical support for improvement projects of other departments. You will also look for new technologies / devices to optimize the process.
- You are in close contact with suppliers of the various devices and ensure that the correct SLA (Service License Agreement) is concluded.
Requirements
- 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
- Language: English
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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.
