Associate MES Engineer

Legend Biotech US-posted 4 months ago
$107,482 - $141,070/Yr
Full-time • Entry Level
Raritan, NJ
1,001-5,000 employees
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Legend Biotech is seeking an Associate MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. The Associate MES Engineer will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing with MES end users to define change requirements while assisting with EBR development and administration at the Raritan site to support production processing. The associate MES Engineer will liaise with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will support the MES team with electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with MES (PAS-X).

  • Work with end users to define MES change requirements
  • Support eBR development, modeling, and deployment in MES
  • Participate in design testing, release planning, and demos with partners
  • Support MES updates with other Supply Chain Systems (ERP, eLIMs, etc.)
  • Support MES validation activities according to the Software Development Lifecycle (e.g. commissioning test Plans (CTP), Installation/Operational Qualification (IOQ))
  • Support updates to standardizations and documentation (e.g. SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures
  • Support Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections
  • Establish key stakeholder relationships with internal and external stakeholders
  • Collect the necessary information and user requirements to ensure that the MES team properly assesses updates and impact
  • A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required. Advanced degree preferred.
  • A minimum of 3 years of relevant experience working in a GMP environment is required.
  • Demonstrated experience working cross functionally with multiple departments translating business needs to change requirements.
  • Cell/Gene Therapy cGMP manufacturing and MES (PAS-X) experience preferred.
  • Working knowledge of MES application and user experience
  • Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously
  • Strong analytical, problem solving and critical thinking skills
  • Clear and succinct verbal and written communication skills
  • Experience in process improvement and implementation of new manufacturing execution system technologies
  • Ability to build strong partnerships and effectively integrate with cross functional collaborators
  • Medical, dental, and vision insurance
  • 401(k)-retirement plan with company match that vest fully on day one
  • Equity and stock options available to employees in eligible roles
  • Eight weeks of paid parental leave after just three months of employment
  • Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays
  • Flexible spending and health savings accounts
  • Life and AD&D insurance
  • Short- and long-term disability coverage
  • Legal assistance
  • Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
  • Commuter benefits
  • Family planning and care resources
  • Well-being initiatives
  • Peer-to-peer recognition programs
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