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Process Optimization Specialist
2 weeks ago
This is an exciting opportunity to join Nordberg Medical AB as a Process Optimization Specialist and drive the development, optimization, and validation of manufacturing processes for our Class III medical devices. As a key member of our team, you will lead cross-functional teams, improve efficiency and product quality, and ensure compliance with regulatory standards.
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 process implementation.
- Develop, document, and maintain process workflows, control plans, and SOPs.
- Conduct process validation activities, including IQ/OQ/PQ.
- Analyze and document validation results, addressing any deviations or non-conformances.
- Collaborate with maintenance and equipment teams to ensure optimal performance of manufacturing equipment.
- 5-8 years of experience in process engineering, with experience in Class III products.
- Bachelor's degree in engineering (Mechanical, Biomedical, Industrial, or Manufacturing). A master's degree is a plus.
- Proficiency in process design, documentation, and validation methodologies.
- Strong understanding of GMP, ISO 13485, FDA 21, and other regulatory requirements.
- Pharmaceutical cleanroom operations experience – Class A to C.
- Freeze drying processes experience in the pharmaceutical industry, preferably EtO.
- Fluent English communication skills.
