Das ist der Job
This position is part of a long‑term project based in the Canton Bern (Switzerland) and requires 100% on-site presence.
Darum lohnt es sich
Responsibilities include, but are not limited to: Execute and manage the CSV lifecycle in accordance with GxP and regulatory requirements Support and drive Computer Software Assurance (CSA) implementation Develop and maintain Requirements Traceability Matrices (RTM) Perform and review risk assessments to ensure compliance and quality standards Define and execute test strategies, including planning and coordination of validation activities Provide validation support for MES, DCS, and PCS systems Collaborate closely with QA, IT, and business stakeholders Ensure adherence to GAMP 5, FDA, and EU regulatory guidelines Required Qualifications: Proven experience in CSV within Pharma, Biotech, or Life Sciences Strong knowledge of GxP, GMP, and regulatory frameworks Hands‑on experience with systems such as MES, DCS, or PCS Solid understanding of CSA principles and modern validation approaches GAMP 5 training/certification required Excellent analytical and documentation skills Fluent in German and English #J-18808-Ljbffr Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries?
PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas. We are seeking an experienced CSV (Computer System Validation) Consultant to support validation activities within regulated Pharma and Life Sciences environments.
The ideal candidate brings strong expertise in GxP compliance, validation methodologies, and computerized systems, along with the ability to operate in complex, cross-functional projects.
