Senior Engineer I, External MSAT

The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide. This role is embedded within MSAT, supporting external GMP manufacturing across chemical and biologic modalities, including lipids, small molecules, VHH antibodies, and plasmids. You will operate as a highly agile technical expert, partnering with CMOs and internal stakeholders to ensure robust execution across technology transfer, validation, and lifecycle management. With a strong focus on data, digital enablement, and continuous improvement, this role offers the opportunity to shape next-generation manufacturing performance while working at the intersection of science, engineering, and emerging technologies such as AI-driven analytics. Here's What You'll Do: • Support technology transfer activities for clinical and commercial products into CMOs, ensuring seamless scale-up and execution • Provide technical support for cGMP manufacturing, including authoring technology transfer documentation and risk assessments • Author and own Moderna-led change controls, while reviewing CMO-owned changes to ensure scientific rigor, appropriate risk assessment, and clear implementation rationale • Review CMO deviations and investigations, ensuring robust root cause analysis, effective CAPAs, and comprehensive product impact assessments; act as SME to challenge and guide investigations • Provide technical oversight of validation activities at CMOs, including protocol review, execution support, and assessment of summary reports • Drive data review, trending, and continued process verification (CPV-style monitoring), establishing data repositories, defining meaningful KPIs, and identifying early signals or process drift • Lead cross-functional troubleshooting and continuous improvement initiatives across manufacturing processes and equipment • Build strong, trust-based relationships with CMO technical and quality teams, influencing without direct authority to deliver right-first-time outcomes • Collaborate closely with internal stakeholders across Quality, Manufacturing, Technical Development, and Supply Chain to ensure alignment and execution • Maintain alignment across global manufacturing sites through shared data, insights, challenges, and standardized solutions • Ensure strict adherence to GxP regulations, internal policies, and compliance standards • Execute tasks in accordance with SOPs, work instructions, and internal documentation standards • Uphold Good Documentation Practices and Data Integrity principles to ensure inspection readiness and audit support • Complete all required training within defined timelines and maintain qualification status The key Moderna Mindsets you’ll need to succeed in the role: “We act with urgency; Action today compounds the lives saved tomorrow.” “We digitize everywhere possible using the power of code to maximize our impact on patients.” Here’s What You’ll Need (Basic Qualifications) Education : B.S, M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.). BS with 7 to 10 years of experience or MS with 4 to 7 years of experience in a pharmaceutical or biotechnology company. Strong GMP experience in a technical/engineering role within Manufacturing Operations and/or MSAT (CMO experience is a benefit). Knowledge of data management tools and statistical analysis. Strong judgment and ability to communicate manufacturing issues in a scientifically sound and clear ... (truncated, view full listing at source)