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Senior Process Development Lead

2 weeks ago

Galway, Galway, Ireland beBee Careers Full time

Senior Process Development Engineer Job Summary

This is a key role within the R&D team where you will work in collaboration with Operations, Quality, and Regulatory teams to transfer, implement, validate, and scale up manufacturing processes.

The Senior Process Development Engineer will be responsible for designing and conducting engineering bench testing as required to investigate and develop appropriate manufacturing processes and specifications. They must ensure that process design and specifications are robust, reproducible, and capable of meeting all qualification requirements.

  • Design and conduct engineering bench testing as required to investigate and develop appropriate manufacturing processes and specifications.
  • Ensure process design and specifications are robust, reproducible, and capable of meeting all qualification requirements.
  • Plan, develop, and execute test methods for process qualification (validation) testing of manufacturing processes.
  • Manage sub-contract manufacturing partners through process qualification (validation) testing and through manufacturing scale-up activities.
  • Support and lead CAPA and NCR investigations from internal manufacturing and sub-contract manufacturing processes.
  • Provide guidance to R&D Engineers, Technicians, and Product Builders.
  • Compile technical documentation to support product development in accordance with ISO 13485 Quality Management System.