Computer System Validation (CSV) Expert

Remote Auto; Polska; Hybrid; PLN 180,000 - 280,000; Full time

Benefits offered by this job

Fully remote

Job summary

Remote Auto is seeking a Senior CSV Expert to lead lifecycle validation for a global IAM platform. You will ensure GxP compliance, maintain the validation strategy, and collaborate across Quality, IT, Security, and business teams to meet regulatory requirements and audit readiness.

The role is fully remote, with work possible from Poland or Ukraine, and focuses on risk-based testing and change control to keep the system validated and compliant.

Qualifications

• Minimum 5 years of experience in system validation within regulated environments.
• Deep expertise in GxP, GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11.
• Strong command of validation documentation practices and lifecycle controls.
• Experience in assessing GxP impact of changes and managing deviations.

Responsibilities

• Define and maintain the validation strategy, scope, and lifecycle controls for the IAM platform.
• Plan, review, and approve complete validation documentation with traceability and risk assessments.
• Lead testing approaches for identity and access management processes and security controls.
• Represent validation in audits and regulatory inspections; explain scope and controls.

Skills

GxP compliance

Validation leadership

Documentation

English proficiency

Tools

GAMP 5

Job description

## Computer System Validation (CSV) ExpertWe are looking for 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 and ready for audits or inspections. You will collaborate with Quality, IT, Security, and business teams to translate regulatory requirements into effective controls. This position is fully remote, allowing you to work from anywhere in Poland or Ukraine. If you are passionate about ensuring compliance in digital identity management, this opportunity may be the right fit for you.Your tasks:Defining and maintaining the validation strategy, intended use, scope, system boundaries, and lifecycle controls for the IAM platform supporting GxP processesPlanning, preparing, reviewing, and approving complete and traceable validation documentation, including requirements, risk assessments, traceability records, test documentation, deviations, and validation reportsDefining a testing approach based on risk and reviewing evidence for key IAM processes such as identity and account management, roles and access rights, and security controlsAssessing changes, software releases, and incidents for GxP impact, and defining the required validation and regression testingManaging validation-related deviations and CAPAs, including investigation support and verification of adequate evidence before closureKeeping the platform in a validated state through effective change and incident management and periodic reviewsClarifying responsibilities and data ownership across IAM and connected applicationsRepresenting IAM validation in audits, regulatory inspections, and management reviews, clearly explaining the validation scope and controlsIdentifying compliance gaps and leading improvements to simplify or automate assurance activitiesRequirements:Minimum 5 years of experience in system validation within regulated environmentsDeep expertise in GxP, GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11Strong command of validation documentation practices and lifecycle controlsProven experience in assessing GxP impact of changes and managing validation-related deviationsAdvanced level of EnglishTax residence in Ukraine requiredNice to haveExperience with IAM platforms and related technologiesFamiliarity with cloud-based solutions and their validation requirementsIntermediate level of Spanish