QA Validation Specialist (m/f/d)

You plan, manage, and oversee qualification and validation activities for equipment and computer-based systems

You create, review, and maintain qualification and CSV documentation

You support and advise related departments—particularly Production, Production Support, Development, and IT—on all CSV-related matters

You act as the interface between the Qualification, CSV, and IT teams

You contribute to digitalization projects in the production environment

You perform QA approvals for maintenance and calibration activities on equipment, utility systems, and relevant systems

You ensure compliance with regulatory requirements (e.g., ISO 13485, MDR, 21 CFR Part 11)

You have a degree in a technical or scientific field (e.g., medical technology, pharmaceutical engineering, information technology, industrial engineering) or a comparable qualification

You have in-depth knowledge of computer system validation (CSV) and a solid understanding of regulatory requirements (ISO 13485, MDR, 21 CFR Part 11, and GAMP 5)

Ideally, you have experience in the qualification of systems/equipment

You have an affinity for IT, software, or digitalization topics and are interested in digitalization projects in production.

You are a strong communicator and enjoy serving as an interface between QA, production, and IT

You are proficient in MS Office and are willing to learn new software systems