Senior Engineer I, External MSAT

Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. 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.

Responsibilities

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

Requirements

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; Knowledge of data management tools and statistical analysis; Strong judgment and ability to communicate manufacturing issues in a scientifically sound and clear way, proposing data-driven options and recommendations; Highly collaborative team player able to work effectively with internal stakeholders and external partners/CMOs in a cross-functional matrix environment; Demonstrated ability to manage multiple priorities and drive projects to completion in a fast-paced environment; Demonstrated ability to proactively identify risks, escalate appropriately, and support issue resolution in a dynamic GMP setting

Nice to have

CMO experience

Benefits

Best-in-class healthcare coverage; voluntary benefit programs; holistic approach to well-being with access to fitness, mindfulness, and mental health support; Family planning benefits including fertility, adoption, and surrogacy support; Generous paid time off including vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown; Savings and investment opportunities; Location-specific perks and extras; Annual discretionary bonus; other incentive compensation; equity award