Process Optimization and Validation Expert

10 hours ago


Stockholm, Stockholm, Sweden Nordberg Medical Full time

Production Process Engineer Job Summary:

Nordberg Medical is looking for a seasoned Production Process Engineer to drive the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices. As a key contributor to our production team, you will be responsible for leading process improvements, collaborating with cross-functional teams, and ensuring compliance with regulatory standards.

Key Responsibilities:

  • Lead process design, development, and optimization for new and existing products.
  • Collaborate with manufacturing teams on production development, technology transfer, and efficient process implementation.
  • Develop and maintain comprehensive documentation related to process design, validation, and improvement activities.

Requirements:

  • 5-8 years of experience in process engineering within the pharmaceutical or medical device industry with Class III product experience.
  • Bachelor's degree in engineering or related field; master's degree is a plus.
  • Strong understanding of GMP, ISO 13485, FDA 21 CFR Part 820 regulatory requirements.
  • Experience with cleanroom operations – Class A to C.
  • Fluency in English (verbal and written).


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