Job Description: The Qualification Engineer (QE) will be responsible for authoring and executing IT/OT qualification deliverables, including Configuration Specifications (CS), Functional Specifications (FS), Installation Qualification (IQ), and Operational Qualification (OQ). Key Responsibilities: • Minimum 5 years of relevant experience in qualification, validation, or a related area. • Supporting business teams in the development of User Requirement Specifications (URS). • Executing qualification protocols and ensuring complete and accurate documentation of all testing activities. • Performing validation of IT/OT systems, including interfaces and system integrations. • Ensuring all qualification and validation documentation complies with ALCOA principles and applicable Novartis procedures. • Supporting CSV activities across both German and French sites, with effective reuse and leveraging of documentation where applicable. • Working under the direction of the Project Compliance Manager (PCM) and the IT/OT organization. • Participating in project review meetings and ensuring adherence to project schedules and milestones. • Contributing to Factory Acceptance Testing (FAT) activities when required. Preferred Candidate Profile: • Strong experience in Computer System Validation (CSV) and qualification of IT/OT systems within regulated pharmaceutical environments. • Experience with qualification documentation, protocol execution, and compliance requirements. • Ability to work effectively in a cross-functional and international project environment.
Qualification Engineer Arbeitgeber: Ampstek
Ampstek ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Genf nicht nur ein dynamisches und innovatives Arbeitsumfeld bietet, sondern auch zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung. Mit einem starken Fokus auf Teamarbeit und individuelle Autonomie fördert das Unternehmen eine Kultur des Wissensaustauschs und der kontinuierlichen Verbesserung, während attraktive Benefits und ein unterstützendes Arbeitsklima die Work-Life-Balance der Mitarbeiter stärken.
