Computer Systems Validation Specialist

🚀 We're Hiring: CSV Lead / Senior CSV Specialist (GxP Systems)📍 Switzerland| 💼 Quality / Production / ITAre you passionate about ensuring that critical GxP systems are reliable, compliant, and audit-ready? Do you enjoy working hands-on across Quality, Production, and IT in an environment that values empowerment, collaboration, and continuous improvement?We are a rapidly growing, purpose-driven organisation focused on supporting the development and delivery of high-quality, patient-centric injectable medicines. As part of our expansion, we are seeking a CSV Lead / Senior CSV Specialist to take ownership of validation activities for key enterprise and laboratory systems.The OpportunityThis is a strategic and hands-on CSV leadership role overseeing system validation across manufacturing, laboratory, and digital functions. You will ensure that systems remain compliant with GAMP 5, data integrity expectations, and regulatory requirements while working closely with system owners to drive operational excellence.You’ll be a visible technical authority and a trusted partner across the organisation, helping teams innovate while maintaining robust compliance.✨ What You'll Do• Lead CSV activities across manufacturing, QC labs, and IT • Develop/review URS, FRS, risk assessments, validation plans & reports • Oversee IQ/OQ/PQ execution and lifecycle documentation • Ensure systems like LIMS, eQMS, MES, ERP, SCADA meet GAMP 5 & data integrity expectations • Support internal teams during audits & inspections • Advise system owners and drive continuous improvement across the organisation✔️ What We're Looking For• Extensive CSV experience in GMP/GxP environments • Strong knowledge of GAMP 5 & data integrity principles • Experience supporting regulatory audits as CSV SME • Familiarity with ERP, LIMS, MES, SCADA, TrackWise, or cloud-based systems • Fluent English + strong German skills • Proactive, collaborative mindset; comfortable working across multiple functions🌱 Why This Role Stands OutYou’ll join a people-centered, innovative organisation with minimal bureaucracy and a genuine focus on patient impact. Expect a highly collaborative culture, room to grow, and the chance to shape how modern, compliant digital systems are scaled across the business.If you're excited by the idea of owning CSV strategy in a dynamic, forward-thinking environment, we’d love to hear from you. 👉 Apply now or reach out directly to learn more.Tshering Sherpatsherpa@planet-pharma.co.uk