Systems Engineer, Digital for Research & Technical Development

Role Summary

Systems Engineer, Digital for Research & Technical Development. Build, integrate, and run/maintain Digital systems across Research and Technical Development. Based in Moderna’s Norwood, MA offices.

Responsibilities

• Translate requirements: Convert system/equipment/data-integration needs from various business groups into robust Digital Lab System solutions.
• Own lifecycle management: Lead end-to-end lifecycle of Digital Systems—including optimizations, maintenance, and version upgrades.
• Integrate systems: Engineer integrations between instruments and digital ecosystems to enable seamless data flow and interoperability.
• Partner and deliver: Collaborate with business analysts, software engineers, and automation engineers to deploy standard or hybrid end-to-end solutions.
• Drive operational excellence: Identify bottlenecks, propose improvements, and implement best practices to increase system reliability, performance, and usability.

Qualifications

• Bachelor’s degree in engineering or related field or relevant experience; a combination of education and experience may be considered.
• 5 - 8 years of experience in manufacturing and lab systems in Pharmaceutical/Biotechnology.
• Experience translating requirements against ISA95/ISA88 structure from I/O to DCS then MES.
• Strong IT and OT technologies knowledge in both continuous and batch processes.
• Proficiency in S88 batch recipe creation, implementation, and troubleshooting.
• Experience with BUS technologies including Fieldbus, HART, Ethernet I/P, OPC; knowledge of Kepware and OPC tools.
• Experience in tech transfer between MST, Process Development, Technical Development and Manufacturing.
• Experience with IQ/OQ/PQ validation for digital manufacturing/lab systems and with computerized system validation per 21 CFR Part 11, Annex 11 and other regulatory requirements.
• Site-based role; not eligible for remote work.

Skills

• Creative, analytical, and strong problem-solving skills.
• Ability to work independently and make timely decisions.
• Ability to work under pressure in a multi-location environment.
• Strong interpersonal skills and ability to build professional relationships.
• Ability to work effectively in a cross-functional, fast-paced project environment.

Education

• No additional education details beyond those in Qualifications.