Engineer Qualification & Validation (m/w/d)

Seniority Level Employee Professional category Industry & Production Percentage of employment 100 % Job type Temporary Reference number KWI-IP-T-54295 Description ### As a First-Tier-Supplier of our renowned business partner, Roche Diagnostics in Rotkreuz, we are looking for a motivated and dedicated Engineer Qualification & Validation, effective immediately or by agreement. The goal is not only to manage documentation, but also to contribute directly to the stability, compliance, and further development of production with one's own expertise. The team is responsible for qualification and validation around the manufacturing equipment. This makes the team an important partner for routine production and for improvements to existing plants and processes. For the Rotkreuz site, we are looking for a personality who likes to take responsibility, works closely with production, and pragmatically advances technical and compliance-related topics. Tasks & Responsibilities ### • Planning and coordinating qualifications of small equipment up to complex production plants • Creating and moderating risk analyses and deriving suitable measures from them • Supporting process and method validations as well as requalifications and revalidations in the event of changes • Actively participating in improvement projects in existing production • Jointly analyzing disturbances, deviations, and technical issues in the production environment with the specialist departments • Evaluating together with internal partners when there is a need for qualification or validation • Independently coordinating with various stakeholders and reliably keeping topics in motion • Providing technical support for audits and representing the area of responsibility in a sovereign manner • Ensuring compliance with regulatory requirements and internal quality standards Must-Haves ### • A completed degree in natural sciences, engineering sciences, or a comparable field of study • 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-related 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 Benefits ### • Become part of one of the most renowned pharmaceutical companies and actively shape the future of healthcare • Experience a corporate culture that promotes diversity and inclusion and in which all employees feel valued • Work on a state-of-the-art campus with green spaces, meeting zones, and an inspiring atmosphere • Work with modern and current tools in an innovative work environment • Start with a professional onboarding and a thorough introduction to your new role during the Welcome Days • Benefit from financial support for your professional development plans • Enjoy a selection of high-quality food in modern company restaurants • As part of a sustainable mobility concept, parking spaces are available on site (according to internal guidelines) • Take advantage of unbeatable, year-round discounts from renowned retailers and over 200 top brands • Benefit from fleet discounts when buying new cars or receive ongoing discounts on fuel with our fuel card Are you interested? Don't hesitate and submit your complete application documents online today. We look forward to you!