Sr. Manufacturing Systems Engineer

Legend Biotech USA; Franklin Township (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading biotechnology company is seeking a Senior Manufacturing Systems Engineer to manage the Manufacturing Execution System (MES). This role involves ensuring system design, implementation, and maintenance in a GxP environment while collaborating with cross-functional teams. The ideal candidate will have extensive experience in MES within the pharmaceutical industry and strong communication skills to facilitate alignment across teams.

Qualifications

• 7+ years experience working with Manufacturing Execution Systems (MES) in a Pharmaceutical or Biotech GxP environment.
• Proven experience implementing or supporting MES systems while meeting Quality and Compliance requirements.
• Strong understanding and experience working in a Cell Therapy manufacturing environment.

Responsibilities

• Lead, deliver, and support global Manufacturing (MES) solutions.
• Define MES standards in alignment with global IT and Manufacturing strategies.
• Develop and optimize system integrations between MES and other Legend Biotech systems.

Skills

Organizational skills

Communication skills

Interpersonal skills

Collaboration

Education

Bachelor's degree in Computer Science, Information Technology, Information Systems, Engineering, or related field

Job 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.

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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.

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.