Senior Process Engineer Life Science

We are seeking an experienced Senior Process Engineer to join our life sciences organisation in Malmö 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&IDs.
• 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 AFRYyou willwork foran inclusiveand braveemployer 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. 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 
 

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. Thats how were 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.

Remote Work :

No

Employment Type :

Full-time