Senior Engineer II, Drug Product Development

The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.

Modernas commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients lives worldwide.

Moderna is solidifying its presence in Norwood a key site in our U.S. manufacturing network where science technology and operations converge. This campus plays a critical role in our end-to-end ecosystem enabling us to deliver mRNA medicines to the world. At Norwood we integrate advanced manufacturing automation and analytical capabilities to support the clinical and commercial production of our innovative portfolio. We are seeking professionals ready to drive impact at scale helping shape the future of Modernas manufacturing and product operations.

Moderna is seeking an accomplished and innovative Shipping Validation Engineer to join the Drug Product Development (DPD) team in Norwood. This individual contributor role will provide end-to-end technical leadership and strategic direction for temperature-controlled (cold chain) shipping system validation across clinical and commercial supply chains. You will play a pivotal role in ensuring the integrity and regulatory compliance of our mRNA medicines throughout global distribution by defining robust shipping strategies leading qualification studies and influencing cross-functional partners to deliver high-quality outcomes.

This role sits at the interface of science engineering and global logisticsoffering a unique opportunity to work with cutting-edge platforms and to shape the future of Modernas pharmaceutical distribution processes. Youll partner closely with Supply Chain Quality Regulatory and Logistics Engineering ensuring cold chain solutions are risk-based regulatory-aligned and support commercial scalability from early development through product launch. The position will also offer significant exposure to Generative AI opportunities for data analysis modeling and smart documentation.

Heres What Youll Do

Your key responsibilities will be:

• Serve as the technical lead and subject matter expert for shipping validation within Drug Product Development.

• Define and implement robust risk-based validation strategies across temperature-controlled distribution systems.

• Design qualify and maintain global shipping systems supporting clinical and commercial product movement.

• Execute distribution and packaging studies including temperature mapping ISO/ASTM testing and thermal modeling.

• Lead lane qualification and lifecycle management activities across validated transport solutions.

• Drive strategic decision-making through risk assessments data analysis and regulatory compliance frameworks.

Your responsibilities will also include:

• Author review and approve technical documents including validation master plans protocols and SOPs.

• Support internal and external audits including health authority inspections and responses.

• Lead investigations CAPAs and change controls related to shipping systems and temperature excursions.

• Collaborate with Quality Regulatory Supply Chain and Engineering to align and execute shipping strategies for late-stage and commercial programs.

• Contribute to global regulatory submissions including INDs BLAs and MAAs by authoring distribution-related sections.

• Provide mentorship to junior engineers in validation strategy technical documentation and compliance standards.

• Advance platform-level initiatives by developing scalable validation approaches and contributing to organizational best practices.

The key Moderna Mindsets youll need to succeed in the role:

• We behave like owners. The solutions were building go beyond any job description.
  You will own the technical space of shipping validation at Modernaleading from the front driving decisions and delivering innovative regulatory-compliant solutions that protect product quality across every shipment every lane and every region.

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  Youll be encouraged to leverage data science and Generative AI tools for temperature modeling data visualization and digital validation documentation pushing the boundaries of how cold chain validation is executed in a digital-first biotech environment.

Heres What Youll Bring to the Table:

• Degree in Chemical/Mechanical/Packaging/Biomedical Engineering Pharmaceutical Sciences or related discipline

• Minimum of 4 years (PhD) 8 years (MS) 10 years (BS) industry experience in biopharmaceutical development focused on shipping validation.

• Experience working closely with external CDMOs and service providers.

• Experience in shipping of parenteral Drug Products and commercialization of a range of relevant drug product images such as pre-filled syringes injection devices and vials

• Knowledge and understanding of product/packaging interaction barrier properties stability global pharmaceutical shipping regulations and distribution testing.

• Ability to work independently as well as part of a team in a highly dynamic fast-paced matrixed environment with rapidly evolving priorities.

• Ability to travel up to 20%.

• This position is site-based requiring you to be at Modernas site full-time. This position is not eligible for remote work.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

• Best-in-class healthcare coverage plus voluntary benefit programs to support your unique needs

• A 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 a discretionary year-end shutdown

• Savings and investment opportunities to help you plan for the future

• Location-specific perks and extras

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 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.

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 to learn more about our current opportunities.

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.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 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.

Accommodations

Were 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 .

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 applicants 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.

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