Process Engineer

Job Title: Process Engineer

• Location: Waterford, Ireland
• Job Type: 23-month Fixed Term Contract
• Work Arrangement: On-site
• Shift: 24/7 - 2 days, 2 nights (12-hour shifts) followed by 4 days off
  

About the job

As a Process Engineer, you'll be at the heart of our sterile manufacturing operations, providing critical engineering support to our pre-filled syringe processes and monoclonal antibody (mAb) commercial production. You'll play a key role in maintaining day-to-day operations while driving continuous improvement initiatives, supporting technology transfers for new products, and enabling capacity expansion. Working within a highly focused and integrated Engineering Team, you'll contribute to delivering life-changing treatments in a state-of-the-art sterile manufacturing environment.

Ready to get started?

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. 

Main responsibilities:

• Own and deliver batch release activities for pre-filled syringe operations, including investigations, work order reviews, root cause analysis, implementing corrective actions, and addressing batch comments from the quality team
• Drive continuous improvement projects across thawing, formulation, filling, filter integrity testing, and sterilization processes to support new product introductions (NPI) and capacity expansion initiatives
• Execute process engineering activities such as cycle development, process improvements, deviation management, and change controls while maintaining compliance and safety standards
• Provide technical support for the aseptic syringe filling line, working with equipment including debagging systems, sterilization units, isolators, and multi-technology filling machines
• Support commercial manufacturing operations by monitoring and improving key performance metrics including safety, quality, delivery, cost, and innovation
• Collaborate with vendors on technology selection and qualification, particularly for single-use systems and new component introductions

About you

• Engineering degree in a relevant discipline
• Strong problem-solving abilities with a methodical approach to identifying and resolving technical challenges
• Excellent documentation skills, including creating and executing protocols to regulatory standards
• Experience working in highly regulated GMP environments with understanding of compliance requirements
• Background in sterile manufacturing operations and processes
• Proven ability to generate clear, accurate technical documentation and reports
• Experience with batch release processes, root cause analysis, or syringe/vial filling operations would be advantageous

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale.
• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
• Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery.

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