About the job
Join Miltenyi Biomedicine as a Computerized System Validation Manager, where you will play a pivotal role in overseeing quality assurance for our validation and qualification processes, with a specific emphasis on Computerized System Validation (CSV). Your expertise will ensure that all activities meet regulatory standards, uphold our internal quality benchmarks, and maintain data integrity. In this position, you will collaborate with diverse cross-functional teams to synchronize validation efforts with our Quality Management System (QMS) and drive continuous enhancements in our QA processes and documentation.
- Lead and supervise validation and qualification initiatives (including CSV), ensuring compliance with GxP, data integrity standards, and our QMS.
- Review and approve validation documentation such as plans, protocols, reports, and risk assessments to guarantee accuracy and alignment with regulatory requirements.
- Develop and maintain comprehensive QA documentation—including SOPs, work instructions, templates, and tools—to support validation, qualification, and change control.
- Provide guidance and training to teams on QA expectations related to validation, qualification, and change management, fostering a culture of quality awareness.
- Conduct QA reviews and approvals within our change management process, ensuring thorough assessment and control of changes affecting validated systems.
- Ensure effective documentation practices, controlled access, and reliable version management, while also contributing to additional QA tasks as required.

