Engineer Qualification & Validation

Engineer Qualification & Validation Roche Schweiz bridges the gap between pharmacy and diagnostics. Important research and development functions are located here. For our long-standing customer, Roche Diagnostics International AG in Rotkreuz, we are looking for an Engineer Qualification & Validation Background: You don't just want to manage documentation, but with your know-how, directly contribute to the stability, compliance, and further development of our production? Then this role is right for you. In our team, we are responsible for qualification and validation around our manufacturing equipment. This makes us an important partner for routine production and for improvements to existing plants and processes. For our site in Rotkreuz, we are looking for a personality who likes to take responsibility, works close to production, and pragmatically drives technical and compliance-related topics forward. Tasks & Responsibilities: • You plan and coordinate qualifications from small equipment to complex production plants. • You create and moderate risk analyses and derive suitable measures from them. • You support process and method validations as well as requalifications and revalidations in the event of changes. • You actively work on improvement projects in our existing production. • You analyze disturbances, deviations, and technical issues in the production environment together with specialist departments. • You assess together with internal partners when there is a need for qualification or validation. • You coordinate independently with various stakeholders and keep topics reliably moving. • You support audits technically and represent your area of responsibility in a sovereign manner. • You ensure that regulatory requirements and internal quality standards are met. Must Haves: • A completed degree in natural sciences, engineering sciences, or a comparable field • 2-3 years of experience in a regulated environment, for example in pharma, diagnostics, medical technology, or a similar industry • Practical experience in qualifying equipment or plants • Knowledge of process and method validation is a plus • Experience with quality-relevant documentation and risk analyses • Technical understanding and interest in production-related topics • A structured, independent, and proactive way of working • Enjoyment of collaboration in interdisciplinary teams • Very good German language skills and good English language skills What we offer: • The opportunity to contribute to one of the most important pharmaceutical companies in the world • Modern campus with plenty of green spaces and meeting zones • Central location with motorway access and railway station nearby • Varied activity profile • Home office possibility • Further training opportunities through temptraining • Collaboration in a dynamic and motivated team • Good compensation You are welcome to send your complete application documents to Mr. Severin Räfle. Chemie Pharma Pharmacy Diagnostics Zug Luzern Full-time Fulltime Research Laboratory