Computer System Validation (CSV) Engineer

GE HealthCare is looking for an experienced Computer System Validation (CSV) professional to join our team in Oslo. This role focuses on validating and maintaining compliant computerized systems, ensuring data integrity and regulatory compliance, while collaborating with Automation, IT, and Quality teams.

Key Responsibilities

• Validation Lifecycle Management: Lead lifecycle validation activities for computerized systems, including automated production equipment, DBR, DCS, BMS, and FMS. Compile and execute validation blueprints (URS, FS, Risk Assessments, Validation Plans).
• Protocol Execution & Testing: Author and execute IQ, OQ, and PQ protocols. Document test deviations, perform root-cause analysis, and manage CAPAs.
• Regulatory Compliance & Data Integrity: Ensure compliance with GxP, GAMP5, Annex 11, and FDA 21 CFR Part 11. Conduct ALCOA+ data integrity assessments.
• Audit Readiness: Maintain systems in a state of audit readiness and support regulatory inspections (NoMA/FDA) as a subject matter expert.
• Cross-Functional Collaboration: Partner with automation, IT, and Quality Assurance to execute system changes via formal Change Control procedures.