Process Engineer Consultant - German speaking

We are looking for a Process Engineer to join our teams in Switzerland and support process engineering activities on biotechnology manufacturing sites (drug substance and/or drug product) in a GMP environment. The position is a permanent contract and a consultant role within our Life Sciences experts (not a contractor).

• Provide process engineering support for biotech manufacturing operations, ensuring robust performance, compliance, and continuous improvement across production areas.
• Lead process troubleshooting on the shopfloor: investigate deviations, identify root causes (RCA), assess product/process impact, and implement effective CAPAs.
• Drive process improvements using data-driven methods (process trending, capability analysis, risk assessments), targeting yield, cycle time, robustness, and right-first-time execution.
• Own or contribute to process changes under GMP change control: define technical rationale, risk evaluation, implementation plan, and effectiveness checks.
• Develop and maintain process documentation: process descriptions, batch records input (M /E ), SOPs, technical reports, and training materials, ensuring alignment with site/global standards.
• Support technology transfer / scale-up / scale-down activities where applicable: process characterization input, run planning, and coordination with MSAT, QC, QA, and production.
• Coordinate and execute process validation / continued process verification (CPV) activities: validation protocols support, sampling plans, data analysis, and validation reporting.
• Participate in cross-functional projects (Engineering, Automation, QA, QC, Supply Chain), ensuring process requirements are captured and translated into practical shopfloor execution.
• Provide process input for equipment and facility topics: URS contributions, design reviews, FAT/SAT support, commissioning readiness, and operational handover.
• Ensure EHS and GMP compliance in daily activities, reinforcing good documentation practices and inspection readiness.

• Degree in Chemical Engineering, Biotechnology, Bioprocess Engineering, Pharmacy, or equivalent.
• Proven experience as a Process Engineer / MSAT / Production Support Engineer in biotechnology / biopharma manufacturing under GMP.
• Exposure to Drug Substance (upstream/downstream, cell culture/fermentation, purification) and/or Drug Product (formulation, filling, lyophilization) is a strong advantage.
• Strong knowledge of GMP documentation, deviation management, change control, and CAPA best practices.
• Experience with process validation/CPV and process data analysis/trending is highly valued.
• Comfortable working in a shopfloor-facing role with multiple stakeholders and shifting priorities.
• Fluent German (C1/C2) and professional English level for global interfaces and documentation.