Senior Validator (f/m/x)

Sii Poland; Szczecin; Remote; PLN 180,000 - 280,000; Full time

Benefits offered by this job

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

Job summary

Sii Poland is seeking a Senior Validator to lead lifecycle validation for a global IAM platform supporting GxP processes. You will translate regulatory requirements into effective controls, collaborate with Quality, IT, and Security, and ensure ongoing compliance as the platform evolves.

Remote work from Poland or Ukraine is supported. You will drive validation strategies, documentation, and testing approaches, ensuring traceability and evidence before release.

Qualifications

• Minimum 5 years of validation experience in regulated environments (GxP).
• 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.
• Experience creating and maintaining validation documentation (requirements, risk assessments, validation reports).
• Proven ability to collaborate with Quality, IT, and Security teams.

Responsibilities

• Define and maintain the validation strategy, scope, boundaries and lifecycle controls for the IAM platform.
• Prepare, review and approve complete, traceable validation documentation before release and during operation.
• Define testing approach based on risk; review evidence for key IAM processes.
• Assess changes for GMP impact and define required validation/regression testing.
• Manage validation deviations and CAPAs; support investigations and closure.
• Keep platform in a validated state via change management and periodic reviews.
• Clarify responsibilities and data ownership across IAM and connected apps.
• Collaborate with Quality, System and Process Owners and service providers to mitigate risks.
• Represent IAM validation in audits and inspections; explain scope, controls and evidence.
• Identify compliance gaps and lead improvements to simplify assurance activities.

Skills

GxP expertise

GAMP 5

EU GMP Annex 11

FDA 21 CFR Part 11

Validation documentation

Cross-functional collaboration

Advanced English

Cloud IAM platforms

Automated validation tools

Spanish (intermediate)

Tools

Cloud IAM platforms

Automated validation tools

Job description

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