Validation engineer

Validation Engineer Validation Engineer: Qualification / Validation / Auditing, / Quality functions MDR / ISO 13485 / 21 CFR 820 / External Manufacturing / Blow Molding / German / English Background: 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 various production technologies 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. The Perfect Candidate holds a Bachelor's Degree in an engineering or scientific/technical field, or equivalent experience, supplemented by at least 10 years of professional background in quality functions like Q\&V or auditing within the Pharma or medical device sectors. The candidate possesses over 5 years of experience in external manufacturing and holds a deep understanding of relevant standards and automated production technologies, such as injection and blow molding. Additionally, the individual demonstrates a consistent commitment to personal and team development, paired with professional\-level communication skills in both English and German. Tasks \& Responsibilities: • Review and evaluate qualification and validation documents and process risk analyses provided by our suppliers • Oversee the assessment of deviations related to qualification and validation activities, ensuring they meet our rigorous standards • Meticulously document the outcomes of your evaluations in compliance with establish...