Process Engineer

Process Engineer (m/f) - Fill & Finish Process Innovation

Location: Schaffhausen, Switzerland

Summary

We are seeking an experienced Process Engineer to join the Drug Product Development & Delivery (DPD&D) Process Innovation team. This role focuses on the development, optimization, and scale-up of fill & finish processes for biologics, while driving innovation and supporting regulatory and technical development activities across multifunctional teams.

Responsibilities

• Lead process development and engineering activities for biologics fill & finish operations.
• Act as innovation lead for projects, identifying and implementing new technologies and process improvements.
• Design, execute, or oversee laboratory studies supporting process development initiatives.
• Develop and apply scale-down models to evaluate critical process parameters and support scale-up activities.
• Investigate and troubleshoot process performance issues using scientific and engineering principles.
• Support technology transfer activities from development to manufacturing.
• Prepare and contribute to regulatory submissions, dossiers, and technical documentation related to fill & finish processes.
• Collaborate with development, manufacturing, and supply chain teams to analyze process data and drive continuous improvement.

Must-Haves

• Bachelor's degree with 9+ years of experience or Master's degree with 6+ years of experience in a relevant scientific or engineering field.
• Strong experience in process engineering within the pharmaceutical or biopharmaceutical industry.
• Proven experience supporting technology transfer and process scale-up activities.
• Knowledge of biologics and sterile fill & finish manufacturing processes.
• Experience with freeze/thaw, mixing, filtration, and filling operations.
• Understanding of Process Analytical Technology (PAT), including tools such as Raman spectroscopy, FlowVPX, or flow sensors.
• Experience troubleshooting manufacturing and process performance issues.
• Excellent communication skills in English and ability to work within cross-functional global teams.