Computer System Validation Specialist (CSV)

Quick Facts

• Role: Computer System Validation (CSV) Specialist

• Focus: GxP-compliant validation of computerized application systems and documentation

Description

Oversee CSV projects covering document management, IT infrastructure, pharmacovigilance, maintenance, and application management. Plan, manage, and execute CSV activities including development of validation documentation, test planning and execution in line with GxP requirements, and maintaining SOPs and project documentation. Ensure GxP compliance and data integrity using ALCOA principles, and support audits/inspections by defending validation practices before regulatory authorities.

Responsibilities

• Plan, manage, and execute CSV projects

• Develop and implement validation documentation

• Plan and conduct tests with proper documentation under GxP

• Create, update, and improve work instructions (SOPs) and related project documentation

• Ensure GxP-compliant operation of application systems

• Support change management adaptations with Quality Management

• Create risk analyses and data maps; apply ALCOA principles for data integrity

• Maintain system validation records and documentation with strict compliance standards

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

• Collaborate primarily with the German branch while employed by the Polish branch; coordinate with other branches and travel to Germany

Requirements

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

• Minimum 2 years of practical experience in computerized system validation (CSV)

• Proficiency with Atlassian tools

• Excellent teamwork, communication, and problem-solving skills

• Polish and English proficiency at C1 level in both written and spoken communication (mandatory)

• Ability to work independently and assertively; reliability and flexibility

• Ability to work autonomously in a dynamic, fast-paced environment

• Proficiency in validation methodologies and quality management systems

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

• Nice to have: understanding of GxP regulations

Benefits

• Co-financing for Multisport/Medicover Sport

• Co-financing for Medicover/LuxMed

• Company Social Benefit (ZFŚS) for social activities for employees and their families

• Quarterly bonuses

• Employee referral program

• Internal and external training and career development

• English classes; advanced learners may study German

• Birthday day off

• Comfortable workstations, laptops, and equipment