Legend Biotech
Role Overview
Legend Biotech is seeking
HVAC Automation & Controls Technician
as part of the
Facilities & Engineering
team based in
Raritan, NJ . 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. The individual will handle 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, ability to work independently, and the capability to effectively communicate, coordinate and collaborate across cross-functional groups to establish a strong, compliant program enabling robust production, testing and release of product to patients. Key Responsibilities
Work with plant functions to implement and maintain tools, standards, policies and procedures in compliance. Handle 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. Conduct local system data performance monitoring and analysis for BAS and EMS. Execute SOPs, including data backup, disaster recovery, user administration, etc. Implement and maintain network configuration for BAS, EMS, and facility automation equipment. Provide training to end users. Provide user-defined reports and facilitate ad-hoc queries. Provide status reports and coordinate with other departments or outside contractors/vendors to complete tasks. Qualifications
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. Deep knowledge of Honeywell and Siemens BAS software, hardware, protocols and IT infrastructure (HC900s, CPO, PXCMs, EBI, Desigo, BACnet, MODBUS, APOGEE P2) is preferable. Experience in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance. Expertise in GMP compliance 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; 600, 601, and 610 are 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, and 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 manage a portfolio of ongoing projects. Attention to detail and adherence to procedures. Highly organized with a collaborative, team-oriented attitude under supervision. Good written and verbal communication skills; ability to summarize and present results; experience with team-based collaborations. Knowledge 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 Batch Records, SOPs, Work Instructions, and protocols. Experience with BAS, EMS, TrackWise, CMMS and Maximo. Familiarity with IT application design and deployment. Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint). Benefits
Medical, dental, and vision insurance 401(k) retirement plan with company match Equity and stock options for eligible roles Eight weeks of paid parental leave after three months of employment Paid time off: 15 vacation days, 5 personal days, 5 sick days, 11 U.S. holidays, 3 floating holidays Flexible spending and health savings accounts Life and AD&D insurance Short- and long-term disability coverage Legal assistance and supplemental plans (pet, critical illness, accident, hospital indemnity) Commuter benefits, family planning and care resources, well-being initiatives Peer-to-peer recognition programs 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. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.
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Legend Biotech is seeking
HVAC Automation & Controls Technician
as part of the
Facilities & Engineering
team based in
Raritan, NJ . 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. The individual will handle 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, ability to work independently, and the capability to effectively communicate, coordinate and collaborate across cross-functional groups to establish a strong, compliant program enabling robust production, testing and release of product to patients. Key Responsibilities
Work with plant functions to implement and maintain tools, standards, policies and procedures in compliance. Handle 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. Conduct local system data performance monitoring and analysis for BAS and EMS. Execute SOPs, including data backup, disaster recovery, user administration, etc. Implement and maintain network configuration for BAS, EMS, and facility automation equipment. Provide training to end users. Provide user-defined reports and facilitate ad-hoc queries. Provide status reports and coordinate with other departments or outside contractors/vendors to complete tasks. Qualifications
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. Deep knowledge of Honeywell and Siemens BAS software, hardware, protocols and IT infrastructure (HC900s, CPO, PXCMs, EBI, Desigo, BACnet, MODBUS, APOGEE P2) is preferable. Experience in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance. Expertise in GMP compliance 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; 600, 601, and 610 are 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, and 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 manage a portfolio of ongoing projects. Attention to detail and adherence to procedures. Highly organized with a collaborative, team-oriented attitude under supervision. Good written and verbal communication skills; ability to summarize and present results; experience with team-based collaborations. Knowledge 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 Batch Records, SOPs, Work Instructions, and protocols. Experience with BAS, EMS, TrackWise, CMMS and Maximo. Familiarity with IT application design and deployment. Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint). Benefits
Medical, dental, and vision insurance 401(k) retirement plan with company match Equity and stock options for eligible roles Eight weeks of paid parental leave after three months of employment Paid time off: 15 vacation days, 5 personal days, 5 sick days, 11 U.S. holidays, 3 floating holidays Flexible spending and health savings accounts Life and AD&D insurance Short- and long-term disability coverage Legal assistance and supplemental plans (pet, critical illness, accident, hospital indemnity) Commuter benefits, family planning and care resources, well-being initiatives Peer-to-peer recognition programs 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. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.
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