Beschreibung

As a CSV Engineer, you will play a vital role in validating computerized systems and ensuring seamless integration across projects. Your day-to-day responsibilities will include preparing documentation, supervising critical system activities, and maintaining high standards during audits.

Anforderungen

• •Bachelor, Master, Diploma from a technical school, university of applied sciences, or equivalent experience
• •Significant experience in a regulated environment with regard to Computerized System Validation (CSV)
• •Good knowledge of Microsoft Office and Delta-V
• •Knowledge of KNEAT, COMOS, DMS, TrackWise, and SAP
• •Proficiency in English, with German language skills being advantageous

Aufgaben

• •Generate and execute validation for computerized systems
• •Follow planning and implementation of CSV activities
• •Prepare commissioning and validation documents for new systems
• •Supervise conversion, expansion, and new construction projects
• •Conduct CSV activities for critical systems in new construction
• •Provide SLC support for all systems post debut
• •Supervise deviations, changes, and CAPAs
• •Coordinate CSV executions with internal groups and external providers
• •Present CSV documents during audits and inspections
• •Schedule and report CSV activities
• •Align CSV strategy with QA CSV for all Biologics scope
• •Contribute to the review and continuous improvement of CSV documents

Tools & Technologien