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Manufacturing Process Specialist

2 weeks ago

Copenhagen, Copenhagen, Denmark Thor Companies Full time

We are seeking a highly skilled Manufacturing Process Specialist to support our manufacturing, process optimization, and regulatory compliance projects across Denmark. This contract role is ideal for independent professionals who want to work on impactful projects without long-term commitments.

Key Responsibilities:

  • Develop and optimize production processes for medical devices, pharmaceuticals, and biotech products
  • Ensure compliance with GMP, ISO 13485, and Danish/EU regulatory requirements
  • Lead validation projects, including process validation, risk assessments (FMEA), and qualification activities
  • Troubleshoot process issues and implement solutions for efficiency and quality improvements

Required Skills:

  • Proven experience in process engineering within the medical, pharmaceutical, or biotech sector
  • Strong knowledge of GMP, ISO 13485, and regulatory compliance requirements
  • Experience with process validation, risk management, and continuous improvement methodologies
  • Flexible and self-driven with the ability to manage project deadlines independently