Reliability Engineer

at  Legend Biotech EU

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.

EDUCATION:

You preferably have a higher technical diploma or can rely on a relevant experience.

EXPERIENCE:

A minimum of three years of experience in maintenance, engineering or operations within an industrial production or regulated environment is required. Experience in a controlled pharmaceutical cleanroom environment under aseptic conditions with knowledge of GMP is preferred.

Key Capabilities, Knowledge, and Skills:

• You have a thorough electro-mechanical experience/knowledge.
• You are a strong communicator and show the necessary dose of assertiveness and self-confidence.
• You are strong in analyzing processes. Is a problem-solver and works systematically.
• You are strong in analyzing processes. Is a problem-solver and works systematically.
• You are transparent, open and have a strong sense of responsibility.
• You appear to be able to multitask, know how to set priorities and have a can-do mentality.
• You can work in a structured and independent way, without losing sight of the team concept and are stress resistant.
• Knowledge of project management, commissioning & qualification (C&Q) and validation are a great added value.
• Knowledge of SAP PM module gives a surplus.
• Bitten to improve both yourself and the installations (= continuous improvement).
• Good understanding of technical installations, process devices, facilities and automated systems within a regulated pharmaceutical environment.
• Ability to identify and solve opportunities within processes, devices and systems.
• Strong knowledge of the English language.
• Team spirit with a positive mindset to strengthen each other.

ROLE OVERVIEW:

This position will be part of the Engineering and Maintenance team within the Technical Operations group and will be responsible for managing and developing reactive, preventive and predictive maintenance activities through safe and compliant manufacturing operations according to cGMP requirements in the clinical and commercial cell therapy production facilities in Ghent, Belgium. This role requires technical expertise and problem-solving skills and will encourage effective communication, coordination and collaboration among relevant cross-functional groups to enable robust production, testing and release of products to patients

MAJOR RESPONSIBILITIES:

• As a 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.
• The Reliability Engineer has a considerable knowledge of the equipment technologies used in lab/cleanroom environments. For specific equipment knowledge you work closely with the Maintenance Engineers. In this role you define and revise the maintenance plans, define the necessary spare parts, develop training materials for the technicians and manage the technical documentation (including the structure in SAP). Cooperation with the Maintenance Manager and the Maintenance Planner are of paramount importance. You are the expert in the RCM (= Reliabilty Centered Maintenance).
• 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 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 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.