We are looking for a Computer System Validation (CSV) Engineer to join our team!

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.

Technical Requirements

• CSV Expertise: Strong proficiency in GAMP5 methodologies and validating automated manufacturing and facility systems.

• System Familiarity: Hands-on validation experience with Siemens/Rockwell PLC/HMI platforms, Honeywell EBI BMS, and validated environmental monitoring software (FMS).

• Industry Experience: Minimum of 5-7 years of dedicated CSV experience within a validated pharmaceutical, biotech, or medical device manufacturing plant.

• Quality Systems: Direct experience using formal Change Control, Deviation Management, and Risk Management frameworks.

Language & Soft Skills

• Norwegian: Native or professional fluency (B2/C1 minimum) required for local regulatory compliance documentation and team collaboration.

• English: Professional working proficiency required for corporate reporting, global policy alignment, and international audits.

• Attention to Detail: Exceptional documentation skills with a commitment to maintaining precise, compliant records under tight timelines.