Computer System Validation (CSV) Engineer

This role is ideal for an experienced Computerized Systems Validation (CSV) professional with 5–7+ years of experience in regulated pharmaceutical, biotech, or medical device manufacturing. The position focuses on validating and maintaining compliant computerized systems, ensuring data integrity and regulatory compliance, while collaborating with Automation, IT, and Quality teams to support audits and system lifecycle management.

Key Responsibilities

Validation Lifecycle Management

• Lead the lifecycle validation activities for computerized systems, including automated production equipment, DBR, DCS, BMS, and FMS.
• Compile, review, and execute validation blueprints, including User Requirement Specifications (URS), Functional Specifications (FS), Risk Assessments, and Validation Plans.

Protocol Execution & Testing

• Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Document test deviations, perform thorough root-cause analysis, and manage Corrective and Preventive Actions (CAPAs) through to closure.

Regulatory Compliance & Data Integrity

• Ensure all computerized systems strictly comply with GxP, GAMP5, Annex 11, and FDA 21 CFR Part 11 regulations.
• Conduct ALCOA+ data integrity assessments on PLCs, HMIs, and environmental monitoring databases to ensure secure data tracking.

Audit Readiness & Maintenance

• Maintain computerized systems in a continuous state of control and audit readiness.
• Support internal and external regulatory inspections (such as NoMA/Statens legemiddelverk or FDA) as the subject matter expert for CSV.

Cross-Functional Collaboration

• Partner closely with automation engineers, IT, and Quality Assurance to execute system changes via formal Change Control procedures.
• Bridge technical communication gaps by explaining complex validation strategies fluently in both Norwegian and English.