We are looking for a Biotech Process Engineer to join our engineering teams in Switzerland and support process engineering activities across biotech manufacturing operations, from process design through routine production support and continuous improvement.

Your responsibilities :

• Lead process engineering activities for upstream and/or downstream manufacturing operations, ensuring robust, scalable, and compliant process performance in line with GMP expectations.
• Provide day-to-day technical support to manufacturing teams, including troubleshooting of deviations, investigation support (root cause analysis), and definition/implementation of corrective and preventive actions (CAPA).
• Drive process optimization and continuous improvement initiatives (yield, cycle time, robustness, cost), using structured problem-solving and data-driven methodologies.
• Author, review, and approve manufacturing and process documentation (process descriptions, risk assessments, batch records, SOPs, change controls), ensuring accuracy, traceability, and audit readiness.
• Support process transfer activities (technology transfer, scale-up/scale-down, introduction of new products), including definition of process parameters, acceptance criteria, and validation strategy.
• Contribute to qualification and validation activities (IQ/OQ/PQ support, PPQ readiness, cleaning validation, process validation), ensuring alignment with regulatory requirements and internal standards.
• Participate in cross-functional project teams (Engineering, MSAT, Quality, Production, Supply Chain), ensuring clear communication, proper prioritization, and timely delivery of action plans.
• Monitor and trend key process indicators (KPIs), identify recurring issues, and implement sustainable improvements through control strategies and performance monitoring.
• Support EHS and operational excellence initiatives, ensuring safe execution of activities and adherence to site procedures and risk controls.

Your profile :

• Bachelor’s or Master’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, or a related Life Sciences discipline.
• Minimum 5 years of experience in biotech process engineering within a GMP manufacturing environment (drug substance and/or drug product).
• Practical knowledge of biotech unit operations (e.g., cell culture/fermentation, harvest, chromatography, filtration, UF/DF, aseptic processing—depending on focus).
• Strong understanding of GMP expectations, deviation management, change control, and documentation best practices in regulated environments.
• Proven experience in troubleshooting complex process issues and leading investigations using structured methodologies (e.g., 5-Why, Ishikawa, DMAIC).
• Familiarity with validation principles and lifecycle approaches to process control and continuous verification.
• Comfortable working in cross-functional teams and managing multiple priorities in a fast-paced manufacturing setting.
• English is a must, french and german are appreciated.