Process Optimization Expert

1 day ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time
Responsibilities

The successful candidate will be responsible for:

  1. Leading the design, development, and optimization of manufacturing processes for new and existing implantable medical device (Class III) products
  2. Collaborating with manufacturing teams and alliance partners on production development, technology transfer, and implementation of efficient, scalable, and compliant production processes
  3. Developing, documenting, and maintaining process workflows, control plans, and standard operating procedures (SOPs)
  4. Conducting process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes
  5. Ensuring validation protocols align with regulatory standards (e.g., GMP, ISO 13485, and FDA 21 CFR Part 820) and are executed effectively to meet quality requirements
  6. Analyzing and documenting validation results, addressing any deviations or non-conformances
  7. Collaborating with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally

We are committed to providing a supportive and inclusive work environment that fosters professional growth and development. If you are a skilled and motivated Production Process Engineer, we encourage you to apply.



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