Sr. Manufacturing Systems Engineer

Legend Biotech • Somerset, NJ

181d • Hybrid

About The Position

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.

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.

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.

What This Job Offers

• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees