Senior CSV Engineer – GxP, Data Integrity & Audits

gehc; Oslo; On-site; NOK 900,000 - 1,200,000; Full time

Job summary

GE HealthCare in Norway is seeking an experienced Computerized Systems Validation (CSV) professional to lead validation activities for computerized systems across manufacturing environments. You will collaborate with Automation, IT, and Quality teams to support audits and lifecycle management, ensuring data integrity and regulatory compliance.

Applicants should have 5–7+ years in regulated pharma/biotech/medical device contexts and be fluent in Norwegian/English.

Responsibilities

• Lead the lifecycle validation activities for computerized systems, including automated production equipment, DBR, DCS, BMS, and FMS.
• Compile, review, and execute validation blueprints (URS, FS, risk assessments, and validation plans).
• Author and execute IQ, OQ, and PQ protocols.
• Document test deviations and manage CAPAs through to closure.

Job description

GE HealthCare in Norway is seeking an experienced Computerized Systems Validation (CSV) professional to lead validation activities for computerized systems across manufacturing environments. You will collaborate with Automation, IT, and Quality teams to support audits and lifecycle management, ensuring data integrity and regulatory compliance.

Applicants should have 5–7+ years in regulated pharma/biotech/medical device contexts and be fluent in Norwegian/English.