Legend Biotech US
Overview
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, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autoleucuel (cilta-cel). 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
HVAC Automation & Controls Technician
as part of the
Facilities & Engineering
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 for day-to-day activities including 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 requires systems engineering experience, ownership and leadership, the ability to work independently, and the capability to communicate, coordinate and collaborate across cross‑functional groups to establish a compliant program that enables 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 interfaces including data management, issues, deviations, corrections, remediation and improvement. Conducts local system data performance monitoring and analysis for BAS and EMS. Executes against SOPs, including data backup and 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. Prefer 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. Attention to detail and adherence to procedures; highly organized and capable of working in a team environment with some supervision. Good written and verbal communication skills; ability to summarize and present results and work with cross-functional teams. 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 and remediate gaps in processes or systems. Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, and 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, PowerPoint). EEO Statement
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 applicable law.
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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, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autoleucuel (cilta-cel). 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
HVAC Automation & Controls Technician
as part of the
Facilities & Engineering
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 for day-to-day activities including 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 requires systems engineering experience, ownership and leadership, the ability to work independently, and the capability to communicate, coordinate and collaborate across cross‑functional groups to establish a compliant program that enables 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 interfaces including data management, issues, deviations, corrections, remediation and improvement. Conducts local system data performance monitoring and analysis for BAS and EMS. Executes against SOPs, including data backup and 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. Prefer 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. Attention to detail and adherence to procedures; highly organized and capable of working in a team environment with some supervision. Good written and verbal communication skills; ability to summarize and present results and work with cross-functional teams. 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 and remediate gaps in processes or systems. Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, and 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, PowerPoint). EEO Statement
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 applicable law.
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