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Production Process Leadership

1 week ago

Malmo, Skåne, Sweden Nordberg Medical AB Full time
Job Description:

As a key member of our team at Nordberg Medical AB, you will play a vital role in driving the development, optimization, and validation of manufacturing processes for our Class III medical devices. This involves leading cross-functional teams to implement advanced manufacturing techniques, improving efficiency and product quality, and ensuring compliance with regulatory standards.

Key Responsibilities:

  • Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device 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).
  • Conduct process validation activities, including IQ/OQ/PQ, for new and modified manufacturing processes.
  • Analyze and document validation results, addressing any deviations or non-conformances.
  • Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally.
Required Skills and Qualifications:
  • Around 5-8 years of experience in process engineering, within the pharmaceutical or medical device industry with experience in at least Class III products.
  • Bachelor's degree in engineering (e.g., Mechanical, Biomedical, Industrial, or Manufacturing Engineering) or related field. A master's degree is a plus.
  • Proficiency in process design, documentation, and validation methodologies, including IQ/OQ/PQ.
  • Strong understanding of GMP, ISO 13485, FDA 21, and other applicable regulatory requirements.
  • Experience with pharmaceutical cleanroom operations – Class A to C.
  • Experience with freeze drying processes in the pharmaceutical industry, preferably EtO.
  • Fluency in English (verbal and written).
Benefits:
  • Ongoing training and development opportunities to foster your professional growth.
  • The chance to join a global, inclusive team where innovation and creativity are actively encouraged.
  • A unique opportunity to contribute to the expansion of both product range and volume.