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.