Manufacturing Excellence Manager

3 days ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

PharmaRelations ApS is seeking a highly skilled Senior Production Process Engineer to join our team. In this role, you will lead and support the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices.

Key Responsibilities
  • Design, develop, and optimize manufacturing processes for new and existing implantable medical device (Class III) products.
  • Collaborate with manufacturing teams and alliance partners to implement efficient, scalable, and compliant production processes.
  • Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).
Process Validation and Qualification:
  • Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes.
  • Ensure validation protocols align with regulatory standards (e.g., GMP, ISO 13485, and FDA 21 CFR Part 820).

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