Develop and execute validation protocols (IQ/OQ/PQ) for software systems and tools used in GxP environments
Author and maintain validation documentation including validation master plans, protocols, reports, and standard operating procedures
Follow comprehensive validation plans following GAMP 5 principles, including risk-based approaches to validation activities
Ensure all validation activities comply with 21 CFR Part 11, GAMP 5, ISO 9001 and applicable FDA guidance
Maintain validation documentation in accordance with quality management system requirements
Support audit and inspection readiness through comprehensive validation records
Partner with Software Engineering, Product Management and Quality Management on developing and reviewing validation artifacts
Support Change Control activities and assess validation impact of system changes
Requirements
Experience in software validation, computer system validation (CSV), or related quality/compliance role within a regulated life sciences environment (pharma, biotech, or medical device)
Strong understanding of GAMP 5 principles and risk-based validation approaches
Working knowledge of 21 CFR Part 11 requirements for electronic records and signatures
Familiarity with ISO 9001 quality management system principles