Process Engineer – with Pharmaceutical Manufacturing Experience

Job Description

As a Process Engineer, you will lead and support the development, optimization, and validation of manufacturing processes. 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

• 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.
• Ensure validation protocols align with regulatory standards and are executed effectively to meet quality requirements.
• 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 implement corrective and preventive actions as necessary.
• Provide technical expertise and training to manufacturing staff on new processes, equipment, and quality standards.
• Ensure all production processes comply with medical device regulations and standards.
• Prepare, review, and maintain comprehensive documentation related to process design, validation, and improvement activities.

Skills and Requirements

• Minimum 3 years of experience in process engineering within the pharmaceutical industry.
• Strong understanding of GMP and other applicable regulatory requirements.
• Proficiency in process design, documentation, and validation methodologies.
• Experience with pharmaceutical cleanroom operations.
• Bachelor’s degree in engineering or a related field.
• Fluency in English, both verbal and written.

Personality

• Curious and Fast Learner.
• Adaptable and Self-Motivated.
• Collaborative Team Player.
• Strong Communicator.

Other Information

This is a remote or on-site role that involves regular business travel to our CMOs, located in Malmö. Additional travel to supplier sites or other company locations will occur based on business needs.