Senior Engineer I, Manufacturing Sciences and Technology

Moderna • Norwood, MA

2d • $109,200 - $174,600 • Hybrid

About The Position

The Senior Engineer I, Manufacturing Sciences and Technology is an individual-contributor role based in Norwood, Massachusetts, reporting to the Sr. Director, MSAT Materials. The role provides technical leadership for consumables and/or raw materials throughout their life cycle, including new material introduction, consumable design, investigations, troubleshooting, supplier change assessments, scale-up, and technology transfer.

The successful candidate applies expertise in GMP quality systems, processing equipment, unit operations, and pharmaceutical manufacturing regulations. The position partners across technical, manufacturing, supply chain, procurement, quality, and regulatory functions to develop material strategies, improve manufacturing processes, maintain regulatory compliance, and support global alignment of testing and Extractables and Leachables (E&L) practices. It also serves as lead writer for BLA and MMA submissions and supports documentation, data integrity, training, and approved uses of Generative AI tools.

The role follows Moderna’s 70/30 work model, with approximately 70% in-office work to support collaboration. The workplace is smoke-free, alcohol-free, and drug-free. Employment is contingent on eligibility to access export-controlled information; only U.S. persons as defined in the posting are eligible, and Moderna cannot sponsor non-U.S. persons for an export control license.

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.
• Strong communication skills to lead technical teams and coordinate effectively across functions.
• Background in GMP quality systems, processing equipment, unit operations, and pharmaceutical manufacturing regulatory guidelines.

Nice To Haves

• 8–12 years of relevant 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, connecting material requirements with manufacturing process needs.
• Troubleshoot process and equipment issues and lead resolution of internal and supplier deviations.
• Drive investigations, including identifying and implementing corrective and preventive actions (CAPAs).
• Lead impact assessments of supplier change notifications and represent the technical function in supplier relationships, collaborations, and troubleshooting.
• Lead writing of 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, including Regulatory, Environmental, Health and Safety, and current Good Manufacturing Practice 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.
• Maintain aligned, current Extractables and Leachables strategies and guidance documents that meet regulatory requirements, and support sites in owning E&L studies and risk assessments.
• Execute work according to internal guiding documents, including standard operating procedures and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements; complete and maintain records for business use and audit and inspection support.
• Complete assigned required training within defined timelines and requalification cadence.
• Explore approved Generative AI applications 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