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Sr. Manufacturing Systems Engineer

Sr. Manufacturing Systems Engineer

CompanyLegend Biotech
LocationSomerset County, NJ, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesBachelor’s
Experience LevelSenior, Expert or higher

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.

Preferred Qualifications

    No preferred qualifications provided.