Senior Engineer I, Manufacturing Sciences and Technology

ModernaTX • Norwood, MA

14h • Hybrid

About The Position

Moderna is hiring an individual-contributor engineer or scientist to provide technical leadership for consumables and/or raw materials throughout their life cycle. Based in Norwood, Massachusetts, the role supports new material introduction, consumable design, investigations and troubleshooting, supplier change assessments, scale-up, and technology transfer. The position requires a strong foundation in GMP quality systems, processing equipment, unit operations, and pharmaceutical manufacturing regulatory guidelines, along with communication skills to lead technical teams and coordinate across functions.

The role connects long-term material strategies with hands-on technical execution. It supports a critical materials improvement roadmap covering supply chain integration, cost savings and avoidance, and simplification of the consumables library. The position also leads BLA and MMA submission writing, coordinates global testing strategies, and supports alignment and site ownership of Extractables and Leachables (E&L) strategies, studies, and risk assessments.

The position is based on Moderna’s 70/30 work model, with 70% in-office collaboration. Employees must follow applicable regulations and company policies, including EHS and cGMP requirements, Good Documentation Practices, and Data Integrity requirements. Approved Generative AI tools may be explored for technical knowledge synthesis and documentation support, with human oversight and compliance with company policies.

Requirements

• BS or MS in mechanical engineering, material science, or a related technical discipline.
• At least 5 years of industry experience in process development, manufacturing, engineering, or a similar technical role.
• Demonstrated aptitude or ability to learn and develop a strong understanding of GxP and GMP regulations.
• Ability to comply with U.S. export control requirements; only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible, and Moderna cannot sponsor non-U.S. persons for an export control license.

Nice To Haves

• 8–12 years of industry experience is preferred.

Responsibilities

• Support and improve processes for introducing new consumables and raw materials, providing technical expertise 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 resolution of internal and supplier deviations.
• Drive investigations by identifying and implementing corrective and preventive actions (CAPAs).
• Lead impact assessments of supplier change notifications and serve as a technical representative in supplier relationships, collaborations, and troubleshooting.
• Coordinate with internal stakeholders to evaluate supplier-change implications for materials and manufacturing processes.
• Serve as lead writer for BLA and MMA submissions, including clinical and non-clinical overviews and summaries, clinical study reports, and other Common Technical Document modules.
• Follow applicable regulations, guidelines, and company policies to ensure compliance with Regulatory, EHS, and cGMP requirements.
• Partner with Technical Development, Supply Chain, Procurement, Quality, and Regulatory Affairs on a critical materials improvement roadmap covering supply chain integration, cost savings and avoidance, and consumables library simplification.
• Ensure global alignment of testing strategies that meet or exceed regulatory requirements.
• Ensure E&L strategies and guidance documents are aligned across sites, current, and compliant with regulatory requirements.
• Work with sites to support site-level ownership of E&L studies and risk assessments.
• Execute tasks according to internal guiding documents, including SOPs and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements and maintain complete records available for business use, audits, and inspections.
• Complete assigned required training within defined timelines and prescribed requalification cadence.
• Explore approved Generative AI tools for technical knowledge synthesis and documentation support while maintaining human oversight and compliance with company policies and Data Integrity requirements.

Benefits

• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs.
• Location-specific perks and extras.
• Potential eligibility for an annual discretionary bonus, other incentive compensation, or an equity award, subject to plan eligibility criteria and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior