Senior Packaging Engineer

7 days ago

Norwood, Massachusetts, United States BioSpace, Inc. Full time
About the Role

We are seeking a highly skilled Senior Packaging Engineer to join our team. As a key member of our packaging engineering team, you will be responsible for designing, developing, and implementing innovative packaging solutions for our products.

Key Responsibilities
  • Design and develop packaging equipment specifications
  • Manage Front End Planning (FEP) activities 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
Requirements
  • Bachelor's or Master's degree in Packaging, Mechanical, or Automation Engineering
  • Minimum 12 years of relevant experience as a Packaging Engineer
  • Minimum 5 years of experience in a GMP environment
  • Technical and regulatory background in labeling and secondary packaging requirements in pharmaceutical/Biotech industry
  • Experience in large capital/expansion programs with direct design responsibility
  • Experience with 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
  • Excellent interpersonal and communication skills (verbal and written)
  • Ability to present own work to peers and cross-functional managers and influence decisions
  • Technical writing skills
  • Ability 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
  • Ability to interact well with other groups and take ownership of and follow through on assignments
  • Ability to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor

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