Senior Validator (f/m/x)

Sii is seeking a Senior Validator to join our team and lead lifecycle validation for a global Identity and Access Management (IAM) platform. In this role, you will ensure that functions supporting regulated GxP processes remain compliant, controlled, and ready for audits while collaborating with Quality, IT, and Security teams to maintain high standards.

Key responsibilities

• Defining and maintaining the validation strategy, intended use, scope, and lifecycle controls for the IAM platform supporting GxP processes.
• Planning, preparing, and reviewing comprehensive validation documentation to ensure adequate evidence is available for releases and operations.
• Assessing software releases and configuration changes for GxP impact and defining necessary validation and regression testing.
• Managing validation-related deviations and CAPAs in accordance with procedures, including investigation support and verification of evidence.
• Representing IAM validation during audits and inspections by clearly explaining validation scope, controls, risks, and evidence.

Requirements

• Minimum 5 years of experience in validation within regulated environments, specifically GxP processes.
• Deep expertise in GxP, GAMP 5, and EU GMP Annex 11 regulations.
• Strong understanding of FDA 21 CFR Part 11 and its implications for system validation.
• Proven ability to collaborate effectively with cross-functional teams including Quality, IT, and Security.
• Advanced level of English.

What we offer

• Fully remote work environment allowing you to contribute from anywhere.
• Opportunity to work on a global-scale IAM platform project.
• Professional development in a dynamic, regulated environment.