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Computer System Validation Engineer
  • Gliwice
Computer System Validation Engineer
Gliwice, Gliwice, Silesian Voivodeship, Polska
Avantor
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

  • Praca Gliwice
  • Gliwice - Oferty pracy w okolicznych lokalizacjach


    105 580
    17 963