Senior CSV / Validation Specialist

DCG is a professional recruitment company dedicated to supporting experienced specialists in their career growth. We are currently seeking a Senior Validation Specialist to join our team and contribute to high-level projects for our global partners.

Key responsibilities

• Determine validation approaches and identify necessary deliverables for GXP computerized systems.
• Review software documentation in accordance with CSV corporate SOPs and regulatory guidance.
• Author validation plans and reports while assessing system readiness for implementation.
• Lead and author system and functional risk assessments to ensure compliance.
• Coordinate validation activities globally and act as a subject matter expert during audits and inspections.

Requirements

• Minimum 3 years of experience in IT and Software Validation (CSV, GAMP), ideally within the pharmaceutical sector.
• Proven experience in leading validation for projects and system maintenance.
• Strong knowledge of SDLC processes and regulatory standards such as 21 CFR Part 11 and Annex 11.
• Hands-on experience with tools like JIRA, ServiceNow, and SAP/MES systems.
• Excellent communication skills in English (C1 level) and the ability to work effectively in cross-functional, global teams.

What we offer

• Private medical care package.
• Co-financing for sports activities.
• Access to professional training and continuous learning opportunities.
• Dedicated consultant support and an employee referral program.