Principal Engineer, Drug Product, Global Engineering Lead

4 weeks ago

Norwood, Massachusetts, United States Moderna Full time
Job Summary:

The Principal Engineer, Drug Product, Global Engineering will lead the design, development, and validation of drug product manufacturing process equipment and facilities globally. This role involves cross-functional collaboration with R&D, Quality, Regulatory, and Manufacturing teams to ensure drug products meet quality, safety, and efficacy standards.

Key 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.
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 to 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.
About Moderna:

Moderna is a leading mRNA technology platform company that aspires to build a world-class team and infrastructure to reimagine how medicines are created and delivered. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. We champion the significant benefits of in-office collaboration by embracing a 70/30 work model, which helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

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