Sr. MES Engineer

The role

The Senior MES Engineer will drive EBR development and administration at the Raritan site to support production processing. This role involves managing interactions with multiple functions and implementing system improvements for MES (PAS-X).

What you will do

• Drive eBR development, modeling, and on time deployment in MES
• Coordinate with other departments to gather user requirements and deliver EBR
• Participate in design testing, release planning, and demos
• Serve as a Subject Matter Expert of MES for CAR-T and site initiatives
• Lead the coordination of MES updates with other Supply Chain Systems
• Execute MES validation activities according to the Software Development Lifecycle
• Define standardization and update documentation including SOPs and protocols
• Support Quality Investigations, Corrections, and QMS as a Site MES SME
• Build Site Readiness of MES for FDA and other Regulatory Audits
• Train Manufacturing Excellence and Operations on MES utilization

Required qualifications

• Bachelor's degree in engineering or related field or equivalent experience
• Minimum of 6-8 years of relevant experience
• Experience translating business needs to system requirements
• Provide technical expertise of Change Control process
• Oversight of the MES team to ensure smooth implementation of system enhancement activities
• Ability to manage shifting priorities to meet critical deadlines
• Strong analytical, problem solving and critical thinking skills
• Clear and succinct verbal and written communication skills

Nice to have

• Advanced degree
• Cell/Gene Therapy cGMP manufacturing experience
• Project planning experience

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight weeks of paid parental leave after three months of employment
• Paid time off including vacation, personal, sick, floating holidays, and eleven company holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans including pet, critical illness, accident, and hospital indemnity insurance
• Voluntary commuter benefits
• Family planning and care resources
• Well-being initiatives and peer-to-peer recognition programs

Before you apply

• Applicants must be authorized to work in the United States
• Participation in the E-Verify program
• Required to complete the Form I-9 process

About the company

Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, the company advances cell therapy through innovative technologies.