Sr. Manufacturing Systems Engineer

Job Description

Legend Biotech is seeking a Sr. Manufacturing Systems Engineer to join their IT team in Somerset, NJ. This role focuses on the technical delivery, design, and maintenance of the company's Manufacturing Execution System (MES). The Senior Manufacturing Systems Engineer will lead discussions between business and technical teams to ensure the MES remains competitive and meets user requirements. This position requires on-site presence at the Raritan/Somerset, NJ facility.Role involves:

• Leading the delivery and support of global Manufacturing (MES) solutions.
• Defining MES standards in alignment with IT and Manufacturing strategies.
• Partnering with global and local site teams to ensure consistency of the MES solution.
• Developing and optimizing system integrations between MES and other Legend Biotech systems.
• Collaborating with Business Process Owners to manage demand intake.
• Leading lifecycle management of MES projects.
• Communicating MES solution strategies.
• Assessing impact to MES and upstream/downstream systems for changes and downtime.

Requirements:

• Bachelor’s degree in Computer Science, IT, Information Systems, Engineering, or related field.
• 7+ years of experience working with Manufacturing Execution Systems (MES) in a Pharmaceutical or Biotech GxP manufacturing environment.
• Experience implementing or supporting MES systems while meeting Quality and Compliance requirements.
• Experience with Computer Systems Validation, Qualification activities, and change controls in a GxP environment.
• Strong understanding and experience working in a Cell Therapy manufacturing environment.
• Experience working with regulatory requirements, including GxP, SOX, and data privacy.
• Outstanding organizational, written, and presentation skills.
• Exceptional interpersonal and communication skills.
• Ability to manage conflicts and negotiations.
• Collaborative skills and the ability to operate across multiple geographies.

Role offers:

• Opportunity to work with a leading biotechnology company.
• Chance to contribute to the development and maintenance of a critical MES system.
• Collaborative and cross-functional work environment.