Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Laboratory Setting

Job Description

Dynabeads produced in Norway are used in break-through technologies, lifesaving assays and clinical applications. Our customers are world leading pharma and diagnostics companies that have chosen us as their partner. Through a strong culture of collaboration both internally and externally, we deliver on high expectations through the quality of our work. Measuring quality in a reliable way is a key requirement from customers and regulatory authorities alike.

We are now looking for a new colleague to join the manufacturing sciences department, a part of Technical Operations, where we offer an outstanding possibility to work with production processes for one of the most exciting technologies within biotechnology. Our work is both exciting and challenging in an international environment with large opportunity for professional and personal growth.

• Process Optimization: Analyze existing manufacturing processes, identify areas for improvement, and implement changes to enhance efficiency, reduce waste, and ensure product quality while maintaining ISO 13485 compliance.
• Continuous Improvement: Participate in process improvement initiatives, including the introduction of new technologies and methods to enhance production.
• Project management: Participate in improvement or NPI projects according to a phase gate approach and communicate efficiently with stakeholders.
• Quality Assurance: Develop and implement quality control procedures to ensure that products meet or exceed ISO 13485 standards, industry regulations, and customer expectations.
• Equipment Evaluation: Evaluate and recommend equipment upgrades or replacements to improve process efficiency and reliability.
• Documentation: Maintain comprehensive documentation of process changes, equipment specifications, MC/commissioning, equipment qualification, process validation and standard operating procedures while adhering to ISO 13485 documentation requirements.
• Multi-functional collaboration: Collaborate with production, facilities, EHS, R&D and quality assurance teams to ensure alignment on process improvements and quality standards.
• Safety Compliance: Adhere to all safety protocols and procedures, ensuring safety in production processes, a safe working environment and compliance with regulatory standards.

• Bachelor/ Master of Science or higher within chemical engineering, industrial biotechnology, or a related field.
• Proven experience in medical device manufacturing or an industrial process facility.
• Experience participating projects within process, biotechnology, or polymer industries preferably within the context of ISO 13485 quality system or similar.
• Strong analytical and problem-solving skills.
• Familiarity with ISO 13485 regulatory requirements specific to the medical device industry or comparable quality management system.

• Experience with Quality by Design and Life Cycle approach to Process Validation

• Fluent in both spoken and written English and a Scandinavian language with excellent technical writing skills.
• Ability to work, communicate and influence efficiently with impactful multi-functional teams in a matrix organization.
• Interest and understanding of the importance of documented quality.
• Results oriented with a high energy, and drive. Adapt quickly to changes and re-prioritizations with a positive demeanor.
• A great teammate with the ability to give/receive constructive feedback.
• Diligent with a dedication to safety and quality.