Computer System Validation Engineer

Miejsce pracy: Gliwice

Technologies we use

Coordinate and lead CSV activities for computerized and automation systems
Act as Subject Matter Expert (SME) in CSV projects
Collaborate with business teams to maintain and improve CSV processes
Develop and monitor test scripts to assess system functionality, reliability, and quality
Define CSV strategy and validation policy for current and future IT systems
Participate in system implementation, maintenance, and retirement projects
Review and approve validation documentation in line with procedures and regulations
Deliver training on software validation and Part 11 requirements
Support internal and external audits as CSV expert
Monitor validation status and conduct periodic reviews of systems

Higher education in a technical field (preferred: IT, engineering, biotechnology, or related)
Professional proficiency in English and Polish
Experience in:
Computerized System Validation (CSV)
Understanding of FDA, EU, and other regulatory requirements for system validation
Working with cross-functional teams (IT, Quality, R&D, Engineering)
IT infrastructure and qualification processes
Internal and external audits (preferred)