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 a HVAC Automation & Controls Technician (Contractor) as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position will be responsible for providing engineering support for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of life cycle management, issues, deviations, corrections, remediation and improvement efforts of automation and controls systems for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require systems engineering experience, ownership and leadership, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant program to enable robust production, testing and release of product to patients.

Key Responsibilities

• Works with above plant functions to successfully implement and maintain tools, standards, policies and procedures in compliance.
• Handling day-to-day activities for BAS, EMS and other automation and controls system software, hardware and associated interfaces inclusive of data management, issues, deviations, corrections, remediation and improvement
• Conducts local system data performance monitoring and analysis for BAS and EMS
• Executes against SOPs, inclusive of data backup, disaster recovery, user administration, etc.
• Implements and maintains network configuration for BAS, EMS, and facility automation equipment.
• Provides training to end users
• Provides user defined reports and facilitates ad-hoc queries
• Provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks

Requirements

• A minimum of a Bachelor's Degree in Science, Engineering, Automation, Information Technology or equivalent technical discipline is required.
• A minimum of 2 years as an automation and controls field service technician. Experience troubleshooting complex systems is a must. It is preferable that the candidate have deep knowledge of Honeywell and Siemens BAS software, hardware, protocols and IT infrastructure (HC900s, CPO, PXCMs, EBI, Desigo, BACnet, MODBUS, APOGEE P2). Working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
• Expertise in GMP compliance knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among others
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
• Thorough knowledge and understanding of GMP data integrity standards
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Proficient in applying process excellence tools and methodologies
• Ability to independently be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Ability to work with others in a team environment.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Ability to identify/remediate gaps in processes or systems.
• Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, protocols.
• Experience with BAS, EMS, TrackWise, CMMS and Maximo
• Familiarity with IT application design and deployment
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
• 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.