CSV Engineer

Computer System Validation (CSV) Engineer – Biotech Our client based in Melbourne is seeking an experienced Computer System Validation (CSV) Engineer to support GMP-regulated automation and data systems within pharmaceutical and biotechnology manufacturing environments. Key Duties • Own and deliver Computer System Validation (CSV) activities for GMP automation and data systems. • Develop and execute validation documentation in accordance with GAMP 5, Annex 11 and 21 CFR Part 11 requirements. • Author and manage Installation Qualification (IQ), Operational Qualification (OQ), risk assessments, traceability matrices and validation reports. • Prepare, review and execute CSV documentation and testing activities for new and existing systems. • Review and approve validation documentation to ensure compliance with quality and data integrity requirements. • Conduct records review assessments and quality assurance reviews of technical documentation, including User Requirements Specifications (URS), Functional Specifications (FS) and Design Specifications (DS). • Coordinate with cross-functional teams to ensure compliance with GMP and regulatory requirements. • Support commissioning and qualification activities, including Site Acceptance Tests (SAT) and Factory Acceptance Tests (FAT). • Implement automation changes through formal change control procedures. • Provide technical support for automation systems and troubleshoot hardware, communications and configuration issues. • Maintain validation records and ensure adherence to ALCOA+ data integrity principles. Required Skills and Experience • Bachelor's degree in Engineering, Biotechnology, Automation, or a related discipline. • Demonstrated experience in Computer System Validation within pharmaceutical or biotechnology manufacturing environments. • Strong analytical, documentation and problem-solving skills. • Ability to manage multiple projects and collaborate effectively with cross-functional teams.