Senior Engineer I, External MSAT
Core
Senior engineering expert supporting external GMP manufacturing for mRNA science, ensuring robust execution across technology transfer, validation, and lifecycle management for chemical and biologic modalities.
Role type
Senior IC manufacturing engineering specialist (MSAT/CMO)
Builds
Scalable mRNA medicine delivery via external CMO partners
Domain
Biopharmaceutical manufacturing / mRNA technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing operations, technology transfer, change control management, deviation investigation, validation oversight, data trending and CPV, cross-functional stakeholder management, risk assessment, regulatory compliance (GxP), data integrity
Preferred skills
CMO experience, AI-driven analytics, statistical analysis, digital enablement
Technologies
GxP regulatory frameworks, data management tools, statistical analysis software
Responsibilities
Support technology transfer activities for clinical and commercial products into CMOs; Author and own Moderna-led change controls; Review CMO deviations and investigations; Provide technical oversight of validation activities at CMOs; Drive data review, trending, and continued process verification (CPV-style monitoring); Lead cross-functional troubleshooting and continuous improvement initiatives
Seniority
Senior, hands-on IC