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.