Senior Process Engineer Life Science

Company Description

AFRY provides engineering, design, digital and advisory services. We are devoted experts in industry, energy and infrastructure sectors, creating impact for generations to come. AFRY has Nordic roots with a global reach.

Our shared principles - Results driven, Client Centric, Empowering and Accountable - guide us in how we work, grow and succeed together. Join us and unlock transitions towards a sustainable and resilient society.

Job Description

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 o