Sr. MES Engineer

About the Role

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 Electronic Batch Record (EBR) development and administration at the Raritan site to support production processing while managing interactions with other functions including Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT.

Responsibilities

• Drive EBR development, modeling, and on-time deployment in MES (PAS-X).
• 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 to ensure successful roll-out of MES updates with minimal corrections/revisions based on end-user feedback.
• Serve as a Subject Matter Expert (SME) of MES for CAR-T and site initiatives requiring MES.
• Lead the coordination of MES updates with other Supply Chain Systems (ERP, eLIMs).
• Drive, coordinate, and execute 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, Work Instructions, 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 Site Readiness of MES for FDA and/or other Regulatory Audits/Inspections.
• Train Manufacturing Excellence and Operations on MES utilization and ensure proper assessment of updates and impact.
• Provide technical expertise on the Change Control process and oversee the MES team to ensure smooth implementation of system enhancement activities.
• Work closely with the development and MS&T organization to translate changes from concept to implementation, building long-term implementation and support plans.
• Manage shifting priorities to meet critical deadlines in a fast-paced and dynamic environment.
• Provide technical recommendations and limitations associated with MES functionality in evaluating potential process changes for effectiveness, value, risk, and priority.
• Drive MES enhancements to reduce COGs and increase throughput, capacity, and quality compliance.
• Work cross-functionally across Technical Operations and interface with IT to design and implement new system updates for cell therapy development and manufacturing.
• Support studies related to process improvement and implementation of new manufacturing execution system technologies.
• Build strong partnerships and integrate with cross-functional collaborators to drive projects/programs forward in a matrixed environment.

Requirements

• A minimum of a Bachelor's degree in engineering or a related field or equivalent experience required; advanced degree preferred.
• A minimum of 6-8 years of relevant experience, including demonstrated experience translating business needs to system requirements.
• Cell/Gene Therapy cGMP manufacturing and project planning experience preferred.
• Ability to accurately and reliably gauge task effort and plan work to meet project timelines.
• Work independently, prioritize, and manage multiple tasks simultaneously while balancing competing priorities effectively.
• Strong analytical, problem-solving, and critical-thinking skills, with the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Clear and succinct verbal and written communication skills.

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 policy including vacation time, personal time, sick time, 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 and supplemental plans (e.g., 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.

Performance-based bonus and/or equity is available to employees in eligible roles.

Pay

Base pay range: $127,313 – $167,099 USD.

Work Authorization

Applicants must be authorized to work in the United States. The company participates in the E-Verify program.