Jobdescription For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Process Engineer. General Information: Start Date: ASAP Latest Possible Start Date: 01.06.2026 Planned Employment Duration: 12 months Extension: unlikely Workplace: Basel Workload: 100% Home Office: possible by arrangement, on-site required Team: 15-25 team members Department: Drug Substance Internal and External Manufacturing (MMN) Working Hours: Standard About the job: As a Process Engineer Downstream, you will provide solutions within the B91 Manufacturing Unit SUT (Single-use Technology) at Basel Drug Substance Manufacturing to ensure safe, high-quality antibody production. You will serve both our patients and employees by developing and implementing process improvements and fostering dialogue and collaboration between local and global functions in Development, Innovation, and Regulatory affairs. The ideal candidate: Has a completed degree, at least 3 years of professional experience, and extensive knowledge in Downstream and/or Upstream processing of biotechnological products. Furthermore, a minimum of 2 years of experience in biopharmaceutical manufacturing or development is required, along with experience working in a cGMP environment. Tasks & responsibilities: Provide technical and scientific support to shifts to ensure robust and efficient manufacturing processes in a GMP environment; includes on-call duty. Plan and coordinate troubleshooting activities and root cause analysis in close cooperation with other Manufacturing Units, Quality, MSAT, and other departments. Manage planned and unplanned events according to GMP guidelines. Review and approve electronic batch protocols for commercial and clinical products (MES-based Batch Record Review). Act in accordance with internal Quality System (PQS) requirements and health authority cGMP regulations. Lead or support optimization projects and the introduction of new technologies or products. Plan, prepare, moderate, and update Quality Risk Assessments for commercial manufacturing to ensure systematic identification and reduction/elimination of GMP compliance risks. Act as the Owner of production processes (interface between Manufacturing, Science, and Technology). Create and present concepts, documents, and assessments during GMP audits and regulatory inspections. Represent the site in network initiatives and communities as needed. Must Haves: Completed degree in Natural Sciences or Engineering (Biotechnology or Bioprocess Engineering preferred). 3–5 years of experience and extensive knowledge in Downstream and/or Upstream processing of biotechnological products. Min. 2 years of experience in biopharmaceutical manufacturing or development Experience working in a cGMP environment. Hands-on experience in Large Molecule Drug Substance manufacturing (Stainless Steel or Single-Use Technology) is an advantage. Experience in tech transfers and Quality Risk Management (QRM) is an advantage. Team player with a high degree of autonomy in a self-directed environment. Excellent communication skills for interacting with the team and local/global interfaces. Excellent written and spoken German and English Sounds interesting? Apply Now! We look forward to receiving your application. Application Submission Deadline: 11.03.2026