We are seeking an experienced Senior Process Engineer to join our life sciences organisation in Malmö, Sweden. In this role, you will lead the design, development, and optimisation of manufacturing processes for our life science clients or in our projects. The successful candidate will play a key role in driving operational excellence, ensuring strong regulatory compliance, and supporting the development of fellow colleagues whilst delivering high-quality and efficient, sustainable solutions for our clients.
- Design, develop, and optimise manufacturing processes for life science products, ensuring scalability and cost-effectiveness
- Conduct process validation studies and prepare technical documentation in accordance with GMP/GXP and regulatory guidelines (FDA, EMA)
- Lead root cause analysis and implement corrective and preventative actions (CAPA) to resolve process deviations and quality issues
- Collaborate with cross-functional teams including quality assurance, operations, research and development and entrepreneurs
- Perform product risk assessments and HAZOP.
- Defining and developing requirements such as URS, room and equipment specifications
- Oversee equipment selection, installation, purchasing and qualification to ensure compliance with operational requirements
- Mentor and guide colleagues and clients, fostering a culture of technical excellence and knowledge sharing
- Prepare and present process improvement proposals to senior management, demonstrating clear business impact
- Maintain up-to-date knowledge of industry best practices, emerging technologies, and regulatory changes within the life sciences sector