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

• 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

• 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

Gliwice - Oferty pracy w okolicznych lokalizacjach