Computerized System Validation Specialist
Summary
Validate computerized systems for a pharmaceutical client, ensuring GxP compliance, managing documentation, and supporting audits in an international team.
At Pretius, we are looking for a Computerized System Validation Specialist to a project in the financial industry, international team.
Project / Role
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.
Requirements
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.
What do we offer?
We focus on long-term relationships based on fair principles and reliability.
Co-financing of the Multisport card and Medicover private healthcare.
Modern office available.
Team bonding activities, internal courses, conferences, certifications.