Computerized System Validation Specialist

Pretius is hiring for a project in the financial industry with an international team.

• 3+ years of hands-on experience delivering Computerized System Validation (CSV) projects.
• Practical knowledge of GxP regulations and validation methodologies.
• Experience working with GAMP 5 guidelines.
• Familiarity with 21 CFR Part 11 and EU Annex 11 (strong advantage).
• Previous experience in the pharmaceutical or life sciences industry is mandatory.
• Experience validating SAP systems is highly preferred.
• Ability to work independently and manage multiple validation activities simultaneously.
• Strong analytical mindset with the ability to critically review technical and validation documentation.
• Experience preparing audit-ready documentation under tight project deadlines.
• Very good communication skills in English.

Nice to have:

• Experience working in consulting or large-scale transformation programs.
• Familiarity with regulated enterprise platforms beyond SAP.
• Experience supporting regulatory inspections or client audits.

• Assess validation gaps and recommend remediation activities.
• Facilitate risk assessments for computerized systems operating in regulated environments.
• Create, review, and remediate validation documentation, including Validation Plans, Validation Reports, and supporting deliverables.
• Manage requirements traceability and maintain GxP-compliant documentation throughout the validation lifecycle.
• Support Operational Qualification (OQ) and Performance Qualification (PQ) testing activities.
• Prepare audit-ready validation evidence and documentation for internal and external inspections.
• Review validation deliverables to ensure completeness, accuracy, and compliance with regulatory requirements.
• Collaborate with business, quality, and technical teams to deliver compliant validation solutions.