Sr. MES Engineer

Legend Biotech US • Raritan, NJ

5d • $110,706 - $145,303 • Onsite

About The Position

Legend Biotech is seeking a Sr. MES Engineer as part of the Manufacturing & Supply team based in Raritan, NJ. The Senior MES Engineer will be a driving member of the Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead. This role is responsible for independently driving and performing EBR development and administration at the Raritan site to support production processing. The individual will manage interactions with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will be accountable for on-time delivery of electronic batch record (EBR) updates while suggesting, evaluating, and implementing system improvements, driving applicable process and facility updates, and supporting qualification activities associated with MES (PAS-X).

Requirements

• A minimum of a Bachelor's degree in engineering or related field or equivalent experience required.
• A minimum of 6-8 years of relevant experience is required.
• Demonstrated experience translating business needs to system requirements.
• Provide technical expertise of Change Control process as well as oversight of the MES team to ensure smooth implementation of system enhancement activities.
• Accurately and reliably gauge task effort and plan work to meet project timelines.
• Work closely with the development and MS&T organization to ensure translation of changes from concept to implementation, building long-term implementation and support plans.
• Work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment.
• An ability to build strong partnerships and effectively integrate with cross functional collaborators to drive projects/programs forward in a matrixed environment.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Clear and succinct verbal and written communication skills.
• Applicants must be authorized to work in the United States.
• Participation in the E-Verify program is required.
• Completion of Form I-9 process and employment eligibility verification through E-Verify is required if selected for employment.

Nice To Haves

• Advanced degree preferred.
• Cell/Gene Therapy cGMP manufacturing and project planning experience preferred.

Responsibilities

• Drive eBR development, modeling, and on-time deployment in MES.
• Coordinate with other departments to gather user requirements, gauge effort, and deliver robust, right-first-time EBR.
• Participate in and deliver design testing, release planning, and demos.
• Ensure successful roll-out of MES updates with minimal corrections/revisions based on end-user feedback.
• Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring MES.
• Lead the coordination of MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).
• Drive, coordinate, and execute right-first-time MES validation activities according to the Software Development Lifecycle (e.g., commissioning test Plans (CTP), Installation/Operational Qualification (IOQ)).
• Define standardization and update documentation (e.g., SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures.
• Act as a Site MES SME to support Quality Investigations, Corrections, and QMS.
• Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.
• Train Manufacturing Excellence and Operations on MES utilization and ensure that Manufacturing Excellence and Operations properly assess updates and impact.
• Provide technical recommendation and limitations associated with MES functionality in the evaluation of potential process changes for effectiveness, value, risk, and priority.
• Drive the implementation of MES enhancements that would provide reduction in COGs, and increase throughput, capacity, and quality compliance.
• Work cross-functionally across Technical Operations and interface with IT to drive the design and implementation of new system updates for cell therapy development and manufacturing.
• Support studies related to process improvement and implementation of new manufacturing execution system technologies when necessary.
• Build strong partnerships and effectively integrate with cross-functional collaborators to drive projects/programs forward in a matrixed environment.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight (8) weeks of paid parental leave after just three (3) months of employment
• Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
• Flexible spending accounts
• 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
• Voluntary commuter benefits
• Family planning and care resources
• Well-being initiatives
• Peer-to-peer recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior