Jobs → Engineering → Cloud CSV / Qualification Engineer

About the Role We are looking for an experienced Cloud CSV (Computer System Validation) / Qualification Engineer to support cloud infrastructure, services, and application validation activities in a regulated pharmaceutical environment. Key Responsibilities • Perform GxP risk assessments for cloud infrastructure, applications, and services • Develop, review, and execute qualification and validation protocols • Perform cloud infrastructure and application qualification activities • Review AWS and Azure cloud configurations for compliance • Execute validation testing and document test results • Identify, investigate, and document deviations and discrepancies • Collect and maintain validation evidence and supporting documentation • Ensure compliance with GxP regulatory requirements and industry standards • Work closely with cloud engineering, IT, QA, and validation teams • Support cloud qualification and Computer System Validation activities • Ensure validation documentation meets regulatory and quality requirements Requirements • Strong experience in Computer System Validation (CSV) • Pharmaceutical or Life Sciences industry experience • Knowledge of GxP regulations and compliance • Hands-on experience with AWS and/or Azure cloud platforms • Experience in cloud infrastructure qualification • GxP Risk Assessment and Validation Testing • Qualification Protocol Development and Execution • Validation Documentation and Evidence Collection • Deviation Management and Root Cause Analysis • Understanding of cloud infrastructure and application architecture Preferred Skills • Knowledge of GAMP 5 guidelines • Experience with Computer Software Assurance (CSA) • Direct experience in AWS or Azure cloud qualification • Knowledge of pharmaceutical quality systems and regulatory compliance • Experience working in regulated IT environments