Advanced Manufacturing Lead

3 days ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

PharmaRelations ApS seeks a highly skilled Senior Production Process Engineer to lead and support the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices.

Key Responsibilities
  • Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device (Class III) products.
  • Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and 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) and are executed effectively to meet quality requirements.
  • Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally.
Continuous Improvement and Optimization:
  • Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
  • Work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Production, to align on process requirements and project timelines.
  • Provide technical expertise and training to manufacturing staff on new processes, equipment, and quality standards.


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