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  • 1 month ago

jobs description

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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Role Overview:

This position will be part of the Engineering and Maintenance organization within the... Technical Operations group and will be responsible to ensure that all production process assets for the cGMP Clinical and Commercial Cell Therapy Manufacturing facilities in Ghent (Belgium) are properly maintained, and all on-site reactive, preventive and predictive maintenance activities are planned and performed in compliance with production schedules. This role will require effective communication, flexibility, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Major Responsibilities:
• Develop and oversee the planning and execution of Engineering & Maintenance activities for production process equipment (e.g., calibration, certification, qualification, reactive and preventative maintenance activities)
• Ensure that all production process assets are properly maintained and all on-site engineering & maintenance activities are planned and performed in compliance with production schedules
• Closely work together with Maintenance & Engineering colleagues to ensure that all critical systems/assets and all maintenance activities in all areas of responsibility comply with all company and/or site Quality & EHS policies and procedures, user requirements, local and federal regulations (e.g., FDA/EU cGMP) and industry standards, guidance and expectations
• Responsible for the technical content and administrative preparation, planning and follow-up of preventative and corrective maintenance activities
• Providing the necessary materials, services, tools, permits, access, etc.
• Making appointments with the user and scheduling to provide access to assets for execution of maintenance & engineering activities
• Coordination with and administrative follow-up of third parties in the event of outsourcing maintenance activities
• Responsible for the administrative processing in the maintenance system of orders, etc.
• Cultivate an efficient, professional and safe working environment and ensure objectives are met within intended time frames
• Ensure capable and qualified (internal and/or external) resources are available to perform maintenance for continuous operation of production process assets
• Assist in developing troubleshooting guides and equipment spare parts lists as required by the asset and/or system
• Ensure documentation of all maintenance activities is properly and timely completed in the computerized maintenance management system (CMMS) following good documentation practices (GDP). Complete all other work associated with the assignment whilst working cooperatively with others
• Contact equipment vendors/suppliers (if applicable) in case of issues
• Ensure contractor and vendor completed work and related documentation meets the necessary maintenance standards and is handed over appropriately
• Lead/support the conclusion of Engineering and Maintenance related quality events including (but not limited to): Notifications, Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, CAPAs, Root Cause Analysis and FMEAs
• Maintain knowledge of and compliance to all applicable codes and regulations as required. Obtain and keep current all required licensing, certifications and training associated with the job
• Support tracking and achievement of annual Engineering and Maintenance goals and objectives including metric improvement targets
• Report performance metrics (e.g., equipment mean time to repair and mean time to failure) and provide/execute corrective action plans
• Prioritize the use of internal and external resources to most effectively achieve business goals and within budget
• Assisting the Maintenance Manager in finding solutions to urgent (unplanned) maintenance problems
• Available for other duties and demonstrate willingness to learn new skills as required
• Develop new systems, practices, policies and procedures (e.g., SOPs, Work Instructions, etc.) pertaining to Engineering and Maintenance activities to enhance the performance of the business

Qualifications

Education:

Master’sDegree in Engineering (Mechanical/Electrical/Bio) or any other related field or equivalent experience required

Experience:

A minimum of five (5) years of experience in maintenance, engineering or operations planning within an industrial manufacturing or regulated environment. Experience in a controlled pharmaceutical cleanroom environment under aseptic conditions is preferred.

Key Capabilities, Knowledge, and Skills:
• Proven planning capabilities. Must be responsible and able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to colleagues
• A good understanding of technical installations, process equipment, facilities and computerized systems within an industrial manufacturing or regulated environment
• Working knowledge of process equipment and instrumentation
• Familiarity with electrical theory, thermal energy principals, mechanical maintenance techniques, and electromechanical theory
• Ability to read and interpret technical English and equipment manuals
• Experience in working with validated and qualified process equipment and systems, and associated documentation
• Broad knowledge and understanding of cGMP, FDA/EU and Industry regulations, standards, guidance and expectations
• Ability to provide support during internal and external regulatory audits
• Self-starter, highly organized and capable of working effectively in a team environment with a positive attitude under some supervision
• Excellent interpersonal and written/oral communication skills, teamwork oriented
• Ability to interact with all levels within the organization and build strong partnerships with Operations, Manufacturing Excellence and Quality
• Ability to pay attention to details and follow procedures
• Ability to summarize and present results, and experience with team-based collaborations is a requirement
• Experience in authoring and executing documentation including, but not limited to: (electronic) Batch Records, SOPs and Work Instructions
• Proficient with using basic computer software packages and Microsoft Office applications (Outlook, Excel, Word and PowerPoint)
• Experience with SAP, CMMS and TrackWise is preferred

Language:

Dutch, English

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
Ghent Belgium

salary-criteria

Apply - Maintenance Planner Ghent