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Computer System Validation Engineer
Gliwice
Nazwa pozycji
Computer System Validation Engineer
Lokalizacja
Gliwice
, Gliwice, Silesian Voivodeship, Polska
Firma
Avantor
Dodano
10. 9. 2025
Informacje o stanowisku
responsibilities :
Coordinate and lead CSV activities for computerized and automation systems for labs and manufacturing
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
requirements-expected :
Education: Higher education in a technical field (preferred: IT, engineering, biotechnology, or related)
Experience:
Ability to perform Computerized System Validation (CSV)
Understanding of FDA, EU, and other regulatory requirements for system validation
Experience with medical devices, pharma or biotech, and related regulations (GMP, GAMP-5, ISO standards, etc.)
Working with cross-functional teams (IT, Quality, R&D, Engineering)
IT infrastructure and qualification processes
Internal and external audits (preferred)
Professional proficiency in English
offered :
Participation in Avantor’s discretionary bonus program
Free Lux Med medical package with the option to include family members
Multisport card / MyBenefit cafeteria with monthly employer contributions
Access to group insurance on favorable terms
Benefits from the Company Social Fund
Employee referral program with attractive rewards
Access to training via LinkedIn Learning and Rosetta Stone
Supportive team and friendly work atmosphere
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