Senior Engineer I, Process Engineering

Responsibilities

• Serve as a technical subject matter expert for Drug Substance processes, including IVT, chromatography, TFF, and LNP formulation
• Support the design, scale-up, and implementation of modular process skids in alignment with GxP requirements
• Develop process flow diagrams (PFDs), P&IDs, and User Requirement Specifications (URS) for manufacturing systems
• Contribute to Clean-In-Place (CIP) system design and optimization to enhance process safety and reliability
• Collaborate with internal stakeholders and vendors to ensure equipment design and automation meet quality objectives
• Support root cause investigations, deviation analysis, and continuous improvement projects
• Mentor junior engineers and contribute to technical excellence within Global Engineering

Requirements

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or a related field
• 7–10 years of experience in process engineering or manufacturing science within a biopharmaceutical or biotechnology environment
• Hands-on experience with Drug Substance processes such as IVT, chromatography, TFF, and LNP systems
• Demonstrated expertise in process simulation and modeling (e.g., mass and energy balances, scale-up modeling)
• Ability to work onsite full-time at the Norwood, Massachusetts location

Preferred Qualifications

• Familiarity with bioprocess skid design, automation, and process analytical technologies (PAT)
• Experience leading cross-functional technical projects in a regulated setting
• Exposure to personalized medicine or individualized manufacturing processes
• Strong understanding of GxP/GMP regulations and FDA, EMA, or ICH standards
• Proven problem-solving skills and ability to manage multiple priorities in a fast-paced environment

Benefits

• Best-in-class healthcare coverage and voluntary benefit programs
• Holistic well-being resources including fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, sabbatical, and global recharge days
• Savings and investment opportunities to assist with future planning

About the Company

Moderna is pioneering the development of a new class of drugs made of messenger RNA (mRNA). We are building the leading mRNA technology platform and the infrastructure to reimagine how medicines are created and delivered. Our mission is to deliver on the promise of transformative mRNA science to bring new medicines to patients worldwide.