Description

Legend Biotech is seeking a Sr. Manufacturing Systems Engineer as part of the IT team based in Somerset, NJ.
Role Overview

The Senior Manufacturing Systems Engineer is responsible for managing the delivery, design, and maintenance of our Manufacturing Execution System (MES) from a technical perspective. This role requires hands-on experience with MES applications, including implementation, Electronic Batch Record (EBR) design principles, system integration, and support/maintenance. In this role, the individual will lead discussions between business and technical cross-functional teams to ensure that our MES remains competitive and to deliver solutions based on our user requirements. The Systems Engineer is part of the Product & Corporate Systems IT team and requires on-site presence at our Raritan/Somerset, NJ facility.

Key Responsibilities

• Lead, deliver, and support of global Manufacturing (MES) solutions, ensuring alignment with cross-functional business and technical teams.
• Define MES standards in alignment with the global IT and Manufacturing strategies.
• Partner with global and local site team Business and Technical Owners 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 internally with stakeholders and externally with MES vendors.
• Lead lifecycle management of MES projects, supporting timelines, testing, and quality requirements to maintain a robust MES landscape.
• Communicate MES solution strategies to raise support and alignment from the business.
• Assess impact to MES and upstream/downstream systems for any changes and/or downtime windows.

Requirements

• Bachelor's degree in Computer Science, Information Technology, Information Systems, Engineering, or related field.
• 7+ years experience working with Manufacturing Execution Systems (MES) in a Pharmaceutical or Biotech GxP manufacturing environment.
• Proven experience implementing or supporting MES systems while meeting Quality and Compliance requirements.
• Demonstrated experience with Computer Systems Validation, Qualification activities, and change controls related to implementation and system changes in a GxP environment.
• Strong understanding and experience working in a Cell Therapy manufacturing environment.
• Proficient experience working with regulatory requirements, including GxP, SOX, and data privacy.
• Outstanding organizational skills with demonstrated ability to prioritize workload and attention to detail.
• Excellent written and presentation skills with the proven ability to communicate with all levels including management and external partners.
• Exceptional interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence
• Demonstrated success collaborating in cross-functional teams.
• Highly collaborative & effective influencing skills and the ability to operate across multiple geographies.

#Li-JT1

#Li-Hybrid

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 autolecuel (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.

Benefits:

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

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.