Senior Engineer I, External MSAT
About 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.
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
- 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
- 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 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
Qualifications
- Experience in technology transfer, cGMP manufacturing, and validation activities
- Strong understanding of data management tools and statistical analysis
- Excellent communication and problem-solving skills
- Ability to work independently and collaboratively in a fast-paced environment
- Proven track record of managing projects and meeting deadlines
- Experience with GxP regulations and compliance
Skills
- Data management and statistical analysis
- Technical writing and documentation
- Project management and coordination
- Collaboration and stakeholder engagement
- Problem-solving and decision-making
- Communication and presentation skills
Benefits
- Best-in-class healthcare coverage
- Family planning benefits
- Generous paid time off
- Savings and investment opportunities
- Flexible work arrangements
Pay & Benefits
The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
Working Model
We believe an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.