IT Validation Engineer (Pharma)

ITP supports ambitious companies in scaling IT, project takeovers, and building specialized teams in outsourcing, recruitment, and consulting models since 2021. They operate in Software Development, Data & AI, Cloud, Cybersecurity, GameDev, and support specialized recruitment outside IT, including the pharmaceutical sector.

• Minimum 3 years experience in CSV / IT system validation
• Experience in pharmaceutical environment (GxP)
• Knowledge of standards and regulations: GAMP 5, FDA 21 CFR Part 11, EU Annex 11
• Experience in creating validation documentation, conducting system validations, risk analyses
• Knowledge of software development lifecycle (SDLC) in regulated environment
• Experience working with Agile and/or Lean methodologies
• Very good English language skills (minimum B2/C1)
• Ability to work with stakeholders and international teams

• Define validation approach for GxP systems
• Identify required validation artifacts and documentation
• Create and review CSV documentation (plans, reports, risk analyses)
• Verify system documentation for compliance with SOP and regulations
• Define test strategies, acceptance criteria, and validation scope
• Coordinate validation activities in projects, including global level
• Collaborate with IT, Quality, and business teams
• Participate in audits and inspections as CSV expert
• Assess impact of changes on validated system state
• Ensure continuous system compliance and audit readiness
• Support data migration and system implementations
• Create and conduct periodic system reviews
• Identify improvements in validation processes