Validation Specialist

ph3Your mission /h3 pbWould you like to contribute to Hartwig’s mission to improve care for patients with cancer? /b br/At Hartwig Medical Foundation (Hartwig), we are dedicated to improving care for patients with cancer through high-quality genomic diagnostics and data. Quality, reliability, and compliance are at the heart of everything we do. To strengthen our Quality team, Hartwig is looking for an experienced Validation Specialist. In this role, you will be responsible for developing and overseeing validation activities across the organization. You will ensure that validation projects comply with applicable regulations and quality standards while supporting colleagues in maintaining an efficient and compliant validation process. /p h3What you will do /h3 pAs our Validation Specialist, you will play a key role in ensuring that our validation processes meet the highest quality and regulatory standards. Your responsibilities will include: /p ul liDeveloping, implementing and maintaining validation workflows in accordance with applicable regulations and quality standards. /li liMonitoring and supporting verification and validation projects from a regulatory and quality perspective. /li liReviewing and approving verification and validation reports to ensure compliance with regulatory requirements and clinical standards. /li liTraining and supporting colleagues involved in verification and validation activities on established workflows, procedures and guidelines. /li liKeeping up to date with changes in relevant regulations and translating these into our quality processes. /li liSupporting broader Quality Management System (QMS) activities, including document control, change management and other quality-related processes. /li /ul h3Your profile /h3 h3bWhat you bring /b /h3 pYou are a quality professional with a structured and analytical approach to your work. You enjoy collaborating with others, communicate with integrity, and understand the importance of maintaining high-quality standards in a regulated environment. You are able to see both the bigger picture and the finer details, work effectively across teams, and confidently promote a strong quality culture throughout the organization. /p pIn addition, you have: /p ul liA Bachelor's degree in Life Sciences or a related field. /li liAt least 7 years of relevant professional experience. /li liExperience working with quality management systems and accreditation standards, preferably ISO 17025, ISO 15189 and/or ISO 13485. /li liExperience working in an accredited environment, ideally within a clinical or diagnostic setting. /li liProven experience in designing, executing and coordinating validation projects. /li liA solid understanding of, or the ability to quickly acquire knowledge of, relevant regulations and quality standards. /li liExcellent organizational skills, with the ability to effectively prioritize work and manage multiple projects simultaneously. /li liA high level of integrity, a strong sense of responsibility and a commitment to maintaining the highest quality standards. /li /ul h3Why us? /h3 h3What we offer /h3 ul liA meaningful position (32–40 hours per week) within a mission-driven, non-profit organization. /li liThe opportunity to work at the intersection of life sciences, data and technology in a rapidly evolving field. /li liA collaborative, open and informal working environment where knowledge sharing and initiative are encouraged. /li liA monthly salary between EUR 3,500 and EUR 5,500 gross, based on experience and skills. /li li26 vacation days (based on full-time employment). /li liA pension plan to which Hartwig Medical Foundation contributes two-thirds of the premium. /li liComplimentary office lunches on Tuesdays and Thursdays, Friday afternoon drinks, and annual team events. /li /ul /p #J-18808-Ljbffr