Validation Engineer Global External Manufacturing (GEM) (m/f/d) 80-100%

at  Roche

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
The Opportunity
This is more than just a validation engineer position. You act as a reliable quality partner, auditor, supplier developer, technical expert and diplomat. As an expert in validation you will work together with our suppliers in qualification and validation projects. With your sound knowledge about quality regulations (e.g. IVDR / MDR, ISO 13485, 21 CFR 820), qualification and validation, and injection molding technology you will ensure that our high-quality products are manufactured in compliance with our standards and external regulations. Your main task is the

supervision of qualification and validation activities with our suppliers. This encompasses process risk analyses, qualification and validation documentation and the corresponding documented evidence.

• You review and evaluate qualification and validation documents provided by our suppliers, conducting thorough process risk analyses
• You oversee the assessment of deviations related to qualification and validation activities, ensuring they meet our rigorous standards
• You meticulously document the outcomes of your evaluations in compliance with established quality standards
• You actively engage in the continuous improvement of processes, providing support in technical matters and performing statistical data analyses
• You offer expert advice to suppliers on quality and compliance, ensuring adherence to all relevant quality standards and specifications
• You thrive in cross-departmental collaboration, working effectively within squads to achieve common goals

Who you are:

• You have a Bachelor’s Degree in engineering, scientific/technical field, or equivalent work experience, with at least 10 years of related experience (Q&V, Auditing, or Quality functions) in Pharma or the medical device industry
• Profound understanding of applicable standards and norms, along with expertise in injection molding technology
• You demonstrate a continuous desire for learning and improvement both for yourself and your team members
• You have excellent communication skills in English and German (written and verbal)

Preferred:

• Knowledge of computerized systems validation and controlled environment qualification (ISO 14644)
• Validation of automated (closed loop) systems
• Certified Lean Six Sigma Green Belt / Black Belt

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be an outstanding opportunity to craft the future of Roche.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche Diagnostics International in Rotkreuz is a leading provider of diagnostic systems solutions, and the largest manufacturer of fully automated in vitro diagnostic systems in Switzerland. We are more than 2’700 passionate colleagues from over 65 nationalities. Find out more about our site in Central Switzerland, here.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer

Please refer the Job description for details