Principal Engineer, Drug Product, Global Engineering

Lead the design and development of aseptic manufacturing processes for Drug Product facilities.,Lead Front End Planning (FEP) activities for 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.,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 and problem-solving.,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.

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.,Ability to present own work to peers and cross-functional managers and influence decisions.,Ability to use technical background to investigate issues using a structured problem-solving approach.,Proficient with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred.,Ability to drive results on multiple complex assignments simultaneously with minimal required direction.

Bachelor's Degree, Master's Degree, PhD

Travel up to 30% at critical project phases.,Position may involve access to U.S. export control laws technology/data; employment contingent on ability to access export-controlled information.,Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.,Moderna is unable to sponsor non-U.S. persons to apply for an export control license.