Senior Engineer II, Drug Product Development

ModernaTX • Norwood, MA

5h • Onsite

About The Position

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's 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 Moderna’s 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 logistics—offering a unique opportunity to work with cutting-edge platforms and to shape the future of Moderna’s pharmaceutical distribution processes. You’ll 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.

Requirements

• 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 Moderna’s site full-time.
• This position is not eligible for remote work.

Responsibilities

• 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.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees