Computer System Validation (CSV) Specialist
CAISydney, New South Wales, Australia
Posted August 25, 2025
Full Time
About the Company
CAI is a professional services firm specializing in accelerating operational readiness and excellence in critical environments. With expertise in owner's project management, continuous improvement, asset management, and more, CAI combines top-tier talent and cutting-edge technology to deliver projects on time and within budget. The company is committed to continuous improvement, real connections, and the highest standards, aiming to lead the industry and build the future.
Job Description
CAI, a 100% employee-owned company, is seeking a Computer System Validation (CSV) Specialist to join their team in Australia. The role involves validating systems within GxP environments, focused on GAMP 5 and compliance with regulatory frameworks. CAI provides commissioning, qualification, and validation services for FDA regulated and mission critical industries.
Requirements
- 3+ years’ experience in CSV in pharma, biotech, or medical devices
- Strong knowledge of GAMP 5, data integrity, and relevant regulatory frameworks
- Experience validating ERP, LIMS, QMS, or equipment-related software
- Detail-oriented, analytical, and proactive team player
- Comfortable working flexibly to meet production schedules
