Om jobbet
Company DescriptionAFRY 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 of industry best practices, emerging technologies, and regulatory changes within the life sciences sector
Qualifications
**Required Qualifications:**
Minimum 8 years' experience in process engineering within the pharmaceutical, biotech, or life sciences manufacturing environment
Proven expertise in process development, scale-up, and optimisation
In-depth knowledge of GMP regulations and FDA/EMA compliance requirements
Experience in developing and updating P&ID's.
Strong analytical and problem-solving capabilities
Experience with process validation and technical documentation
Project management skills with the ability to manage multiple initiatives simultaneously
Demonstrated people skills and experience working effectively within cross-functional teams
Strong written and verbal communication skills in English
Proficiency in at least one of the Scandinavian languages and English
Driving license (B)
**Desirable Qualifications:**
Lean Six Sigma certification
Experience with life science manufacturing
Experience of cleanroom requirements and design
Knowledge of Quality by Design (QbD) and risk management methodologies
Proven track record of mentoring and developing junior staff
Experience from other disciplines within the life science industry such as automation, QA, building, HVAC or sustainability
Experience in technology transfer and scale-up projects
Knowledge of environmental, health, and safety (EHS), and ATEX regulations
Additional Information
At AFRY you will work for an inclusive and brave employer, with sustainability at heart!
In addition to this, we offer the below stated and more:
28 days holiday + 23rd of December. We have flexible public holidays, which means that a Swedish public holiday can be swapped to a public holiday in another culture.
Collective agreement
Work life balance.
Access to many activities through our social club: Club AFRY.
Competitive benefits regarding pension, wellness, and parental leave
Company discounts with external partners through our benefits portal Benify.
Does this sound like your next challenge? Apply already today - We are looking forward to it!
Last day of application 2026-05-31. This is an ongoing recruitment process, which means that the role might be filled before last day of application.
Contact information for questions about the job:
Jonas Persson
Section Manager
jonas.persson@afry.com (mailto:jonas.persson@afry.com)
At AFRY, we engineer change in everything we do. Change happens when brave ideas come together. When we collaborate, innovate technology, and embrace challenging points of view. That's how we're making future. We are actively looking for qualified candidates to join our inclusive and diverse teams across the globe. Join us in accelerating the transition towards a sustainable future.
