Principal Engineer, Drug Product, Global Engineering

ModernaTX • Norwood, MA

9h • Onsite

About The Position

The Role: The Principal Engineer, Drug Product, will lead the design development, fabrication, and validation of drug product manufacturing process equipment and facilities throughout Moderna's global footprint for both Clinical and Commercial supply operations. The Principal Engineer will be expected to maintain timeliness, accuracy, and thoroughness throughout the project lifecycle, leading projects in the Drug Product Engineering discipline and Aseptic Operations. This role involves cross-functional collaboration with R&D, Quality, Regulatory, and Manufacturing teams to ensure that drug products meet quality, safety, and efficacy standards. The Principal Engineer will also mentor junior engineers and contribute to strategic initiatives within the department. This role is based in Norwood, MA and reports to the Director of Global Engineering. Travel to support global manufacturing expansion could be up to 30% at critical project phases.

Requirements

• Ph.D. in Chemical Engineering, Mechanical, or a related field with 8+ years of relevant experience, or M.S. with 10+ years of relevant experience, or B.S. with 12+ years of relevant experience.
• Extensive experience in aseptic processing and sterile manufacturing.
• Proven track record of successful commissioning, qualification, validation, and commercialization of aseptic processes.
• Strong knowledge of GMP, ICH guidelines, and regulatory requirements for aseptic operations.
• Experience with various aseptic techniques and equipment (e.g., isolators, cleanrooms, sterilization methods).
• Excellent problem-solving and analytical skills.
• Strong project management and organizational abilities.
• Effective communication and interpersonal skills.
• Ability to work collaboratively in a cross-functional team environment.
• Proficiency in using aseptic process development and validation tools.
• Experience in large capital/expansion programs with direct design responsibility.
• Expected to be able to present own work to peers and cross-functional managers and influence decisions.
• Must be able use technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions for complex problems.
• Proficient with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred.
• Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from supervisor.
• Ability to represent Moderna’s mindsets, objectives, and policies in a professional and responsible manner.

Responsibilities

• Lead the design and development of aseptic manufacturing processes for Drug Product facilities.
• Lead Front End Planning (FEP) activities for the fill finish equipment scope on capital projects and programs.
• Lead equipment vendor selection and assessments.
• Develop user requirements, design specifications, process parameters, and FMEA assessments.
• Develop and maintain contamination control strategies to prevent microbial contamination.
• Ensure all aseptic operations adhere to Good Manufacturing Practices (GMP) and other relevant guidelines.
• Lead strategies for aseptic process commissioning, qualification and support Media Fills and process validation, support protocols development in compliance with regulatory requirements (e.g., FDA, EMA).
• Prepare and review technical documentation, including validation reports, standard operating procedures (SOPs), and regulatory submissions.
• Serve as a Subject Matter Expert and work closely with Manufacturing and other functional groups to implement and scale up aseptic processes.
• Provide technical leadership and guidance to junior engineers and others in equipment design, problem-solving efforts and troubleshoot aseptic process issues.
• Identify new technologies in aseptic processing and sterile manufacturing technologies.
• Drive results by owning deliverables and assuring on-time milestones completion in capital projects.
• Mentor and train team members on best practices in aseptic operations.

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: Principal
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees