Principal Engineer, DP Packaging Equipment

The Role In this role, you will lead the Label and Secondary Packaging Engineering efforts for capital projects across Moderna's global operations, supporting both clinical and commercial supply chains. The engineer will also provide technical guidance to existing manufacturing facilities. Here’s What You’ll Do Lead the development of labeling and packaging equipment specifications. Manage Front End Planning (FEP) activities, working cross-functionally to define scope, design, manufacturability, cost, capital, risk, and schedules for capital projects. Drive vendor selection and assessment processes for packaging equipment. Provide input into user requirements, design specifications, process parameters, and FMEA assessments. Establish and maintain best practices and functional standards for packaging to promote global standardization of equipment, processes, and systems. Translate business needs into engineering solutions, incorporating an understanding of both commercial and clinical secondary packaging requirements. Act as the Subject Matter Expert (SME) for secondary packaging, driving alignment on procedures and standards within internal and cross-divisional teams. Execute and direct the design of processes and equipment, leveraging innovative engineering techniques and benchmarking both internally and externally. Identify and evaluate new technologies for secondary packaging equipment and printed materials, conducting testing as part of the technical roadmap. Provide technical support to Moderna’s external supply manufacturing network, troubleshooting issues, recommending design improvements, and contributing to continuous improvement efforts. Lead and manage capital projects, ensuring adherence to project timelines and preventing delays. Participate in all phases of engineering projects, from conceptual design to commissioning, validation, and qualification. Troubleshoot equipment failures, contribute to preventative maintenance plans, assess change controls, and support continuous improvement initiatives. Review and guide the work of vendors and consultants while managing multiple complex assignments simultaneously. Develop and update Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment. Additional duties as may be assigned from time to time Here’s What You’ll Need (Basic Qualifications) A Bachelor’s or Master’s degree preferably in Packaging, Mechanical or Automation Engineering. Other engineering degrees will be considered. Minimum of 12 years of relevant experience as a Packaging Engineer Here’s What You’ll Bring to the Table (Preferred Qualifications) Minimum 5 years of experience in a GMP environment A technical and regulatory background in labeling and secondary packaging requirement in pharmaceutical/Biotech industry. Experience in large capital/expansion programs with direct design responsibility Experience with a Thermoforming, Heat Sealing, Plunger Insertion Side Load and Top Load Cartoning, Flexible Packaging Line Design, Vision Inspection Systems, Serialization and on-line barcode printing and verification and coding, Working knowledge of, Automatic Inspection and Clinical Packaging Operations would be preferred. Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence decisions. Technical writing skills required. Must be able use his/her technical background to investigate issues using a structured problem solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems. Familiarity with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred. Ability to interact well with other groups and must be able to take ownership of and follow through on assi ... (truncated, view full listing at source)