Location: Stein, AG, Switzerland Start Date: ASAP Contract Duration: 6 months (with the possibility of extension) Your Mission: • Ensure GMP compliance for critical utilities (e.g., clean water, clean steam, compressed gases), facilities (e.g., HVAC, clean rooms, cold rooms), and process support systems (e.g., autoclave, CIP/SIP) throughout the project management lifecycle from design to qualification, validation, and handover. • Oversee the development and execution of CQV (Commissioning, Qualification, and Validation) plans for GMP systems in alignment with Quality policies and Standard Operating Procedures (SOPs). • Review and approve CQV plans, protocols, and reports, including project-related CQV documents (e.g., User Requirements Specifications (URS), Factory Acceptance Testing (FAT)/Site Acceptance Testing (SAT), Installation Qualification (IQ)/Operational Qualification (OQ)). • Provide quality oversight on CQV documentation and manage related change controls. • Lead and guide staff on qualification and validation issues, ensuring smooth execution of tasks. • Manage and resolve Quality deviations, changes, and Corrective and Preventive Actions (CAPAs) promptly, while escalating issues when necessary. Your Background: • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field. • Significant experience in the GMP-regulated pharmaceutical industry, preferably in a Quality Unit role. • Proven experience in a QA or Engineering role focused on Clean Utilities related to aseptic fill-finish processes and facilities. • Fluency in English; German is an advantage. What We Offer: • An opportunity to work on impactful CAPEX projects within a leading pharmaceutical company. • A dynamic role in ensuring the highest standards of GMP compliance. • A chance to contribute to a dedicated team in Stein, AG with a focus on innovation and quality. If you're a detail-oriented QA professional with expertise in Clean Utilities, we'd love to hear from you Apply now or reach out directly to Veronika von Mentzer, Recruiter: veronika.nakevswisslinx.com