IT Employee - Computer System Validation (m/f/d)

Computer system validation: You plan, coordinate and perform computer system validation according to applicable regulations such as ISO 13485:2016, MDSAP and IVDR. Validation documentation: You create and maintain CSV documents such as validation plans, risk analyses, test concepts, test reports and SOPs. Qualification & Testing: You support the implementation of qualification and test activities (IQ/OQ/PQ). Interface management: You work closely with quality management as well as specialist areas. Audit management: You accompany audits and inspections in the field of computerised systems. Change Control: You evaluate and implement changes within the change control process. Process development: You support the further development of the validation strategy and the standardization of internal processes.

Qualification: You have successfully completed training in the STEM field or a comparable qualification. Professional experience: You have already gained first experience in computer system validation or in quality-regulated environment, for example according to ISO 9001 or ISO 13485:2016. Knowledge of relevant guidelines and standards, in particular ISO 13485:2016, MDSAP, IVDR, GAMP 5, Annex 11 and Part 11. Documentation competence: You have very good knowledge in the field of technical and quality documentation. System knowledge: You have a secure handling of MS Office as well as programs for visual process representation. Working methods: You are characterized by analytical and self-responsibility. Personal competencies: You convince by communication strength, team capacity and a structured way of working. Language skills: You have very good knowledge of German and English in word and writing.

Work-Life-Balance: Mobile work, flexible working hours, additional holiday days and long-term account to enable a Sabbatical. Remuneration: Attractive salary package including Christmas and holiday money. Precautions: occupational pension provision with attractive employer subsidy and asset-effective benefits. Further development: Individual onboarding and a wide range of training opportunities for personal and professional development. Fit & Healthy: Health and sports services such as massages at work. Canteen: Fresh Bowls, Veggie-Day, Stirred Wednesday and much more in our in-house canteen with fresh seasonal cuisine in organic quality daily. Extras: JobTicket Premium, Service Wheel, Kindergarten Grant, Corporate Benefits, EAP and other attractive extras. Location: Attractive location in Darmstadt with ideal connection to the A5, sufficient staff parking and charging facilities for electric vehicles. .