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Senior Manufacturing and Automation Engineer

1 month ago

Fort Lauderdale, Florida, United States Jobot Full time
Job Summary

Dice is the leading career destination for tech experts at every stage of their careers. Our client, Jobot, is seeking a skilled Senior Manufacturing and Automation Engineer to join their team.

This is an exciting opportunity to work with a leading pharmaceutical company that is expanding its operations. As a Senior Manufacturing and Automation Engineer, you will be responsible for leading device engineering activities in the context of pharmaceutical research and development (R&D).

Key Responsibilities
  • Provide technical leadership in device development and manufacturing.
  • Lead and execute manufacturing activities of devices with a focus on orally inhaled and nasal drug products (OINDPs).
  • Develop and implement best practices for manufacturing commercial products.
  • Develop and propose vision, strategy, policies, processes, and procedures to aid and improve business performance.
  • Lead scale-up and commercialization efforts.
  • Lead root cause investigations.
  • Lead life-cycle management efforts.
  • Lead and execute technical analyses including statistical analysis and tolerance analysis.
  • Document studies and author documents per US FDA, EMA, MHRA, and other global health authority requirements.
  • Interface and lead activities with third-party contract research, development, and manufacturing organizations.
  • Ensure that manufacturing strategies and processes are in place to meet business objectives and operational needs in terms of price, quality, and delivery targets.
Requirements
  • A M.S. in Mechanical Engineering, Electrical Engineering, Material Sciences, or a related discipline with 6 to 9 years of experience, or a B.S. with 12 to 16 years of device development experience in the pharmaceutical or related field.
  • Experience with device development and manufacturing in the context of pharmaceutical R&D and product development.
  • Expert knowledge and experience with commercial-scale device manufacturing and assembly processes, including manual, semi-automated, and/or commercial-scale automated processes.
  • Expert knowledge of manufacturing processes, including injection molding and metal machining processes.
  • Expert knowledge of mold tool design, optimization, qualification, and life-cycle management.
  • Expert knowledge of mechanical design with a preference for SolidWorks.
  • Expert knowledge of tools to conduct statistical and tolerance analysis.
  • Knowledge of regulations and standards, including US 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, EU MDR, etc.
  • Experience in development of orally inhaled and nasal drug products (OINDPs) is a plus.
  • Experience with Notified Bodies and CE marking is a plus.
  • Strong English language skills, including writing ability and oral communication.
  • Demonstrates good judgment as well as cultural, social, and environmental awareness.

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