GxP & System Validation Expert (Male/Female)

GxP & System Validation Expert

Start: September 2026

Duration: 6-12 months + extensions

Location: Krakow, Poland

Working model: Hybrid

Contract: Freelance / Contract

Role Overview

We are seeking an experienced GxP & System Validation Expert to assist with ERP Cloud migration activities within a regulated Life Sciences and manufacturing environment. The role will focus on Computer System Validation (CSV), GxP compliance, and validation strategy, ensuring that ERP migration and deployment activities meet required regulatory and quality standards.

The ideal candidate will offer a blend of expertise in ERP Cloud migration, system validation, and GxP/CSV, with a preference for experience with Infor M3.

Key Responsibilities

• Define and execute CSV/GxP validation strategies for ERP Cloud migration activities.
• Ensure compliance of ERP migration and implementation activities with relevant Life Sciences regulatory requirements and validation standards.
• Develop and maintain validation documentation throughout the project lifecycle.
• Support system qualification, risk assessments, validation planning, and execution.
• Coordinate and support validation testing activities, including the review and approval of test evidence.
• Ensure appropriate traceability between requirements, risks, testing, and validation deliverables.
• Support audit readiness, ensuring documentation is complete and inspection-ready.
• Collaborate closely with business, Quality, QA, IT, and technical teams during testing and deployment.
• Identify validation and compliance risks and support relevant mitigation activities.
• Provide guidance on GxP expectations during ERP migration and system implementation activities.
• Support deployment/go-live activities from a validation and compliance perspective.

Key Skills & Experience

Essential:

• Strong experience in Computer System Validation (CSV).
• Solid understanding of GxP and regulated Life Sciences environments.
• Proven experience in defining and executing validation strategies.
• Experience with ERP implementation or Cloud migration projects.
• Strong understanding of risk assessments, qualification, testing, and validation documentation.
• Experience collaborating with Quality/QA, business, and technical stakeholders.
• Strong documentation and audit-readiness experience.
• Ability to work in a hybrid environment in Krakow.

Highly Desirable:

• Experience with Infor M3.
• Experience in manufacturing environments.
• Direct experience supporting Infor M3 Cloud/ERP Cloud migration.
• Background in Life Sciences, pharmaceuticals, or biotechnology.
• Experience with regulated ERP transformation or migration programs.
• Knowledge of GAMP 5 and risk-based validation approaches.
• Experience supporting audits or inspections.

Apply online using the form below. Only applications matching the job profile will be considered.