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We're supporting a cutting-edge med-tech company developing a new manufacturing process and looking for a Process Engineer | Process Scientist to play a key role in establishing and scaling this within a new environment. This is a hands-on role, working at the intersection of process development, engineering, and regulated manufacturing, supporting the delivery of a clinical-stage product.
Job Responsibility:
Support the qualification of a new cleanroom and manufacturing equipment
Develop and validate aseptic manufacturing processes (including media fills)
Contribute to the design, optimisation, and transfer of manufacturing processes
Ensure processes meet PIC/S GMP and regulatory requirements
Lead or support process troubleshooting, root cause analysis, and continuous improvement
Assist in developing process documentation, protocols, and validation reports
Work cross-functionally with engineering, quality, and operations teams
Requirements:
Minimum 2-5 years' experience in process engineering / process development
Background within pharmaceutical, medical device, or GMP-regulated environments
Experience working with aseptic processes, cleanrooms, or regulated manufacturing
Strong understanding of process validation, qualification (IQ/OQ/PQ), and GMP standards
Hands-on mindset with the ability to work on the floor and solve real-world problems
Strong communication skills and ability to work within cross-functional teams
Nice to have:
Experience with bio-manufacturing processes
Exposure to scale-up or process transfer environments
Experience in early-stage / R&D-led manufacturing environments