Computerized System Validation Manager (m|f|d)

As a Computerized System Validation Manager, you provide quality assurance oversight and support for Miltenyi Biomedicine’s validation and qualification activities, with a particular focus on Computerized System Validation (CSV). You ensure that these activities comply with applicable regulatory requirements, internal quality standards, and data integrity principles. In this role, you collaborate closely with cross-functional teams to align validation efforts with Miltenyi Biomedicine’s Quality Management System (QMS) and contribute to the continuous improvement of QA processes and documentation.
 

• You execute and oversee validation and qualification activities (including CSV) and ensure compliance with GxP, data integrity standards, and our QMS.
• You review and approve validation documentation such as plans, protocols, reports, and risk assessments to ensure accuracy and regulatory alignment.
• You develop and maintain QA documentation—including SOPs, work instructions, templates, and tools—supporting validation, qualification, and change control.
• You guide and train our teams on QA expectations related to validation, qualification, and change management, fostering strong quality awareness.
• You provide QA review and approval within our change management process, ensuring proper assessment and control of changes impacting validated systems.
• You ensure structured documentation, controlled access, and reliable version management, while contributing to additional QA tasks as needed.