Computer System Validation (CSV) Specialist

Quick Facts

• Role: Computer System Validation (CSV) Specialist

• Focus: Oversee and execute CSV projects and ensure GxP-compliant operation of computerized systems

Description

Oversee CSV projects spanning documentation management, IT infrastructure, pharmacovigilance, maintenance, and application management. Plan, manage, and execute validation activities including test planning/execution and creation of GxP validation documentation. Ensure compliance with data integrity requirements using ALCOA principles and defend validation practices during audits/inspections.

Responsibilities

• Plan, manage, and execute CSV projects

• Develop and implement validation documentation

• Plan and conduct tests with required documentation under GxP

• Create, update, and further develop work instructions (SOPs) and project documentation

• Ensure GxP-compliant operation of application systems

• Support adaptations and changes (change management) with Quality

• Create risk analyses and data maps; implement the ALCOA principle

• Maintain system validation records with data integrity and compliance standards

• Participate in audits and inspections; defend validation documentation before regulators

Requirements

• Degree in computer science, pharmaceutical engineering, process engineering, or similar

• Minimum 2 years of practical CSV experience for computerized systems

• Proficiency with Atlassian tools

• Polish and English proficiency at C1 level (written and spoken)

• Ability to work independently and autonomously; strong teamwork, communication, and problem-solving

• Strong validation methodology and quality management system knowledge

• Ability to perform risk assessments, validation planning, protocol development, testing, and reporting

Benefits (after the trial period)

• Co-financing for Multisport/Medicover Sport

• Co-financing for Medicover/LuxMed

• Company Social Benefit fund (ZFŚS)

• Quarterly bonuses

• Employee referral program

• Internal and external training; English classes and opportunity to study German

• Birthday extra day off

• Comfortable workstations and required equipment