BioSpace
Overview
Sr. Manufacturing Systems Engineer
role at
BioSpace . 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. Legend Biotech entered into a global collaboration with Janssen to jointly develop and commercialize cilta-cel (ciltacabtagene autoleucuel). The Senior Manufacturing Systems Engineer is part of the IT team based in Somerset, NJ and focuses on the Manufacturing Execution System (MES) from a technical perspective. The role requires hands-on experience with MES applications, including implementation, Electronic Batch Record (EBR) design principles, system integration, and ongoing support/maintenance. The incumbent will lead discussions between business and technical cross-functional teams to ensure MES remains competitive and aligned with user requirements. On-site presence at our Raritan/Somerset, NJ facility is required. Key Responsibilities
Lead, deliver, and support global MES solutions, ensuring alignment with cross-functional business and technical teams. Define MES standards in alignment with global IT and Manufacturing strategies. Partner with global and local site teams to ensure alignment and consistency of a global MES solution. Develop and optimize system integrations between MES and other Legend Biotech systems, including automation systems. Collaborate with Business Process Owners to manage and prioritize demand intake, including support and enhancement requests. Facilitate continuous improvement and feedback opportunities for MES with stakeholders and MES vendors. Lead lifecycle management of MES projects, supporting timelines, testing, and quality requirements. Communicate MES solution strategies to raise support and alignment from the business. Assess impact to MES and upstream/downstream systems for changes and downtime windows. Requirements
Bachelor’s degree in Computer Science, Information Technology, Information Systems, Engineering, or related field. 7+ years of experience with Manufacturing Execution Systems (MES) in a pharmaceutical or biotech GxP manufacturing environment. Experience implementing or supporting MES systems with Quality and Compliance requirements. Demonstrated experience with Computer Systems Validation, Qualification activities, and change controls in a GxP environment. Strong understanding of and experience in a Cell Therapy manufacturing environment. Proficient with regulatory requirements including GxP, SOX, and data privacy. Excellent organizational skills with the ability to prioritize workload and attention to detail. Excellent written and presentation skills with ability to communicate with all levels including management and external partners. Strong interpersonal and communication skills with ability to align cross-functional teams and manage conflicts. Demonstrated success collaborating in cross-functional teams. Highly collaborative with the ability to influence across multiple geographies. Compensation and Benefits
The anticipated base pay range is
$123,605 - $162,232
USD. Benefits
We offer a best-in-class benefits package designed to support well-being, financial stability, and long-term career growth. Highlights include medical, dental, and vision insurance; 401(k) with company match; paid parental leave (eight weeks after three months); vacation, personal, and sick days; paid holidays; and additional benefits such as flexible spending accounts, life and disability insurance, legal assistance, and various voluntary benefits. We also provide commuter benefits, family resources, well-being initiatives, and peer-to-peer recognition programs. EEO Statement
Legend Biotech is an 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 Legend may adjust base salary or other compensation at any time. Legend Biotech maintains a drug-free workplace.
#J-18808-Ljbffr
Sr. Manufacturing Systems Engineer
role at
BioSpace . 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. Legend Biotech entered into a global collaboration with Janssen to jointly develop and commercialize cilta-cel (ciltacabtagene autoleucuel). The Senior Manufacturing Systems Engineer is part of the IT team based in Somerset, NJ and focuses on the Manufacturing Execution System (MES) from a technical perspective. The role requires hands-on experience with MES applications, including implementation, Electronic Batch Record (EBR) design principles, system integration, and ongoing support/maintenance. The incumbent will lead discussions between business and technical cross-functional teams to ensure MES remains competitive and aligned with user requirements. On-site presence at our Raritan/Somerset, NJ facility is required. Key Responsibilities
Lead, deliver, and support global MES solutions, ensuring alignment with cross-functional business and technical teams. Define MES standards in alignment with global IT and Manufacturing strategies. Partner with global and local site teams to ensure alignment and consistency of a global MES solution. Develop and optimize system integrations between MES and other Legend Biotech systems, including automation systems. Collaborate with Business Process Owners to manage and prioritize demand intake, including support and enhancement requests. Facilitate continuous improvement and feedback opportunities for MES with stakeholders and MES vendors. Lead lifecycle management of MES projects, supporting timelines, testing, and quality requirements. Communicate MES solution strategies to raise support and alignment from the business. Assess impact to MES and upstream/downstream systems for changes and downtime windows. Requirements
Bachelor’s degree in Computer Science, Information Technology, Information Systems, Engineering, or related field. 7+ years of experience with Manufacturing Execution Systems (MES) in a pharmaceutical or biotech GxP manufacturing environment. Experience implementing or supporting MES systems with Quality and Compliance requirements. Demonstrated experience with Computer Systems Validation, Qualification activities, and change controls in a GxP environment. Strong understanding of and experience in a Cell Therapy manufacturing environment. Proficient with regulatory requirements including GxP, SOX, and data privacy. Excellent organizational skills with the ability to prioritize workload and attention to detail. Excellent written and presentation skills with ability to communicate with all levels including management and external partners. Strong interpersonal and communication skills with ability to align cross-functional teams and manage conflicts. Demonstrated success collaborating in cross-functional teams. Highly collaborative with the ability to influence across multiple geographies. Compensation and Benefits
The anticipated base pay range is
$123,605 - $162,232
USD. Benefits
We offer a best-in-class benefits package designed to support well-being, financial stability, and long-term career growth. Highlights include medical, dental, and vision insurance; 401(k) with company match; paid parental leave (eight weeks after three months); vacation, personal, and sick days; paid holidays; and additional benefits such as flexible spending accounts, life and disability insurance, legal assistance, and various voluntary benefits. We also provide commuter benefits, family resources, well-being initiatives, and peer-to-peer recognition programs. EEO Statement
Legend Biotech is an 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 Legend may adjust base salary or other compensation at any time. Legend Biotech maintains a drug-free workplace.
#J-18808-Ljbffr