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).
Your Responsibilities
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 (MBR/EBR), 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.
Your Profile
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.