Senior Engineer I, Manufacturing Sciences and Technology

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.Reporting to the Sr. Director, MSAT Materials, you will join a dynamic and influential team as an experienced engineer or scientist in an individual contributor role based in Norwood.You will provide technical leadership for consumables and/or raw materials across the material life cycle, from new material introduction and consumable design to investigations, troubleshooting, supplier change assessments, scale-up, and technology transfer.You will bring a strong background in GMP quality systems, processing equipment, unit operations, and pharmaceutical manufacturing regulatory guidelines, using strong communication skills to lead technical teams and coordinate effectively across functions.Here’s What You’ll Do:Support and improve business processes for introducing new consumables and raw materials, providing the technical expertise and guidance needed to establish robust unit operations and long-term material strategies. Contribute to consumable design and support scale-up and technology transfer activities, connecting material requirements with manufacturing process needs.Troubleshoot process and equipment issues and lead the resolution of internal and supplier deviations. Drive investigations through the identification and implementation of corrective and preventive actions (CAPAs), bringing technical rigor to problem-solving across materials, equipment, and unit operations.Lead impact assessments of supplier change notifications and serve as a technical representative in supplier relationships, collaborations, and troubleshooting, coordinating with internal stakeholders to evaluate implications for materials and manufacturing processes.Serve as the lead writer for BLA and MMA submissions, including the preparation of clinical and non-clinical overviews and summaries, clinical study reports (CSRs), and other key modules in the Common Technical Document (CTD) format.Follow all relevant regulations, guidelines, and company policies to ensure compliance with internal Regulatory, Environmental, Health and Safety (EHS), and current Good Manufacturing Practice (cGMP) requirements.Partner with Technical Development, Supply Chain, Procurement, Quality, and Regulatory Affairs to drive a critical materials improvement roadmap encompassing supply chain integration, cost savings and avoidance, and consumables library simplification. Ensure global alignment of testing strategies that meet or exceed regulatory requirements.Ensure Extractables and Leachables (E&L) strategies and guidance documents are aligned across sites, kept current, and meet all current regulatory requirements. Work with sites to support site-level ownership of E&L studies and risk assessments.Execute tasks precisely as defined in internal guiding documents, including, but not limited to, standard operating procedures (SOPs) and work instructions.Follow Good Documentation Practices and Data Integrity requirements, ensuring that data, documentation, and records are completed and maintained for business use and remain available to support audits and inspections.Complete training in your assigned required learning plan within the defined timelines and according to the prescribed requalification cadence.Explore opportunities to apply Generative AI tools, where approved, to technical knowledge synthesis and documentation support, maintaining human oversight and compliance with company policies and Data Integrity requirements.The key Moderna Mindsets you’ll need to succeed in the role:“We act with dynamic range, driving strategy and execution at the same time at every step.” You will connect long-term material strategies and the critical materials improvement roadmap with hands-on investigations, supplier change assessments, and precise execution of technical responsibilities.“We digitize everywhere possible using the power of code to maximize our impact on patients.” You will seek opportunities to use digital approaches and approved Generative AI tools to support technical knowledge sharing and documentation workflows while upholding quality and data integrity expectations.Here’s What You’ll Need (Basic Qualifications)Education: BS/MS in mechanical engineering, material science, or related technical disciplineExperience: Minimum of 5 years of industry experience in process development, manufacturing, engineering, or similar technical role. 8-12 years preferred.Demonstrated aptitude or ability to learn to gain a strong understanding of GxP and GMP regulations.Our Working Model As we build our company, we have always believed 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. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.Moderna is a smoke-free, alcohol-free, and drug-free work environment.Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Competitive healthcare, plus voluntary benefit programs to support your unique needsA holistic approach to well-being, with access to fitness, mindfulness, and mental health supportFamily planning benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investments to help you plan for the futureLocation-specific perks and extrasThe 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. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.About ModernaSince 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. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Equal OpportunitiesModerna 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. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. AccommodationsWe’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at View email address on click.appcast.io. 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. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. -SummaryLocation: Norwood, Massachusetts; Drug ManufacturingType: Full time