Senior Validator (f/m/x)

Sii Poland; Poznań; A distancia; PLN 120.000 - 180.000; Jornada completa

Descripción de la vacante

Sii Poland seeks a Senior Validator to lead lifecycle validation for a global IAM platform, ensuring GxP compliance and readiness for audits. Remote work is supported across Poland and Ukraine, with collaboration across Quality, IT, and Security to translate regulatory requirements into practical controls.

You will drive validation strategy, documentation, and testing, while managing changes and ensuring ongoing validated state. English proficiency is essential for cross-border collaboration.

Formación

• 5+ years of validation experience in regulated environments (GxP).
• Deep knowledge of GxP, GAMP 5, and EU GMP Annex 11 regulations.
• Strong understanding of FDA 21 CFR Part 11 implications for validation.
• Experience creating validation documentation: requirements, risk assessments, validation reports.
• Advanced level of English.

Responsabilidades

• Define and maintain the validation strategy, scope, and lifecycle controls for the IAM platform.
• Prepare, review, and approve complete validation documentation with traceability.
• Define risk-based testing for IAM processes like identity, accounts, and access rights.
• Assess changes/releases for GxP impact and define validation and regression tests.
• Manage deviations and CAPAs per procedures and verify evidence before closure.
• Maintain validated state through change control, periodic reviews, and supplier oversight.
• Clarify responsibilities and data ownership across IAM and connected apps.
• Represent IAM validation in audits and inspections, explaining scope, controls, and risks.
• Identify compliance gaps and lead improvements to automate assurance activities.

Conocimientos

GxP knowledge

Regulated validation

Cross-functional collaboration

Documentation skills

Advanced English

Descripción del empleo

We 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, controlled, and ready for audits. You will collaborate with various teams, including Quality, IT, and Security, to translate regulatory requirements into effective controls and apply a consistent validation approach as the platform evolves. This position offers the flexibility of remote work, allowing you to contribute to an important project from anywhere in Poland or Ukraine. If you are passionate about maintaining compliance in a dynamic environment, 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 processes
• Planning, preparing, reviewing, and approving complete and traceable validation documentation, ensuring adequate evidence is available before release and during operation
• Defining 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 controls
• Assessing changes, software releases, and configuration changes for GxP impact, and defining the required validation and regression testing
• Managing validation-related deviations and CAPAs in accordance with applicable procedures, including investigation support and verification of evidence before closure
• Keeping the platform in a validated state through effective change management, periodic reviews, and supplier oversight
• Clarifying responsibilities and data ownership across IAM and connected applications
• Working with Quality, System, and Process Owners, and service providers to resolve risks and deliver compliant solutions
• Representing IAM validation in audits and inspections, clearly explaining the validation scope, controls, risks, and evidence
• Identifying compliance gaps and leading improvements to simplify or automate assurance activities

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
• Practical experience in creating and maintaining validation documentation, including requirements, risk assessments, and validation reports
• Proven ability to collaborate effectively with cross-functional teams, including Quality, IT, and Security
• Advanced level of English

Nice to have

• Experience with cloud-based IAM solutions
• Familiarity with automated validation tools
• Intermediate level of Spanish

Job no. JOB-E2M32

Sii ensures that all hiring decisions are made solely on the basis of qualifications and competence. We are committed to equal and fair treatment of all, regardless of legally protected characteristics. At Sii, we promote a diverse and inclusive work environment, in full compliance with applicable anti-discrimination laws.

Benefits For You

• Great Place to Work
• Solid financial situation
• Contracts with the biggest brands
• Centre of internal trainings
• Many experts you can learn from
• Open and accessible management team
• Profit sharing
• Passion Sponsorship program
• Regular integration events and trips
• Comfortable and well-equipped offices
• MySii app
• Medical care