Process Engineer

As
Process Engineer,
you will lead and support the development, optimization, and validation of manufacturing processes for Nordberg Medical. We aspire to produce our products according to cGMP in every step possible.

This role involves supporting scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced manufacturing techniques. You will play a crucial role in problem-solving and troubleshooting production issues while driving continuous improvement initiatives to enhance manufacturing capabilities while ensuring compliance with regulatory standards.

Key Responsibilities
Your responsibilities will include, but not be limited to:

Process Design And Development

• 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.
• 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.

Continuous Improvement And Optimization

• Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
• Lead root cause analyses for any process failures or deviations, and in collaboration with the Quality Department implement corrective and preventive actions (CAPAs) as necessary.
• 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.
• Collect and analyze production data to monitor process performance and identify areas for improvement.
• Generate reports, metrics, and presentations for management, summarizing process performance, validation activities, and improvement initiatives.

Regulatory Compliance And Documentation

• Ensure all production processes comply with medical device regulations and standards, including FDA, GMP, ISO, and other applicable guidelines.
• Prepare, review, and maintain comprehensive documentation related to process design, validation, and improvement activities.
• Participate in audits and regulatory inspections, providing technical support and documentation as required.

Equipment Management And Maintenance

• Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally.
• Support the installation and validation of new equipment, ensuring it meets process requirements and regulatory standards.

Skills and requirements
Experience & Qualifications

• Minimum 3 years of experience in process engineering within the pharmaceutical industry.
• Bachelor's degree in engineering (e.g., Mechanical, Biomedical, Industrial, or Manufacturing Engineering) or a related field. A Master's degree is a plus.
• Proficiency in process design, documentation, and validation methodologies, including, e.g., IQ/OQ/PQ.
• Strong understanding of GMP and other applicable regulatory requirements.
• Experience with pharmaceutical cleanroom operations.
• Experience in processes such as mixing, filling, freeze-drying, or sterilisation within the pharmaceutical industry.
• Fluency in English, both verbal and written.

Personality

• Curious and Fast Learner: Demonstrates a strong desire to learn and grow, quickly grasping new concepts while staying updated on industry trends and best practices.
• Adaptable and Self-Motivated: Thrives in dynamic environments, takes initiative, and leads projects independently with a proactive, solution-oriented mindset.
• Collaborative Team Player: Works effectively across departments, building trust and strong relationships with both internal and external stakeholders to drive cross-functional success.
• Strong Communicator: Communicates clearly and concisely, both in writing and verbally, with the ability to present complex information in a way that is easy to understand.

Other Information
This is a hybrid-based role that involves regular business travel to our CMO in Malmö. Occasional travel to our CMO in Uppsala and our headquarters in Stockholm is also required. Additional travel to supplier sites or other company locations may occur based on business needs.