We are making a difference with innovative technology in healthcare.
Definiens is an expanding multi-national software company based in Munich, Germany, with offices in the United States. We develop cutting-edge automated image and data analysis solutions for the development of tissue-based diagnostics. Definiens products are built on our unique Cognition Network Technology platform, which represents a quantum leap in digital image analysis.
Our pioneering spirit drives us forward in our quest to improve life by advancing pharma research and healthcare. Do you want to be part of this quest? Be part of an innovative software and research company that implements cloud-based Cognition Network Technology® to help treatment of patients with cancer through personalized healthcare.
Help us to ensure highest quality within the continuous integration procedure in the responsible role
Validation Manager (m/f)
together with a skilled and highly motivated QA team members in Munich.
- Planning and implementation of validation projects for Compliant GxP Computerized Systems
- Development and maintenance of validation documentation in compliance to GAMP 5 standard
- Review and approval of validation test protocols and reports
- GxP assessment for regulated IT systems in regards to patient safety, data integrity and product quality
- Support and consulting in regards of implementation and documentation of validation activities
- Development of a Validation Master Plan (VMP)
- Guidance of Initial Risk Assessment and Functional Risk Assessment
- Internal trainings about validation following GAMP 5
Qualifications & Skills
- Degree in Bioinformatics, Computer Science, Computer Engineering, or a similar qualification
- Minimum 5 years work experience in computer system validation in a regulated environment i.e. life science industry
- Advanced knowledge in regards to GAMP 5, PIC/S, FDA guidance and best practices
- Expert knowledge about common regulations e.g. 21 CFR Part 11, 21 CFR 820, EU GMP Annex 11
- Software quality assurance or software development, dealing with sophisticated and technically focused client server products
- Good IT and software life cycle management knowledge
- High level of self motivation and a good attention to detail
- Strong verbal and written communication skills in English
- Team player
- Certified Professional for Medical Software
- Experience with validation of medical devices
- Experience and good technical knowledge of cloud-based systems
- Experience in agile methodology and Scrum
- Good knowledge about process validation
- A challenging and rewarding position as integral part of our development team working with cutting-edge technologies
- The opportunity to work within a highly motivated and qualified team of experts with a proven track record to hit goals
- A stimulating cosmopolitan working environment in Munich
- Excellent working culture with a competitive salary and ongoing career and professional development