Computerised Systems Validation Specialist
About the Role
Our client, a leading pharmaceutical manufacturer, is seeking an experienced Computerised Systems Validation (CSV) Specialist to support validation activities across Production and Packaging operations.
This role is responsible for the validation, compliance, and lifecycle management of computerised systems and equipment, ensuring systems remain fit for purpose and compliant within a GMP-regulated environment.
Working closely with Production, Engineering, Quality, and Global stakeholders, you will support both new system implementations and existing system upgrades and improvements.
This is an excellent opportunity to work on a diverse range of manufacturing systems and contribute to key site projects within a highly regulated pharmaceutical workplace.
Note: Successful candidates will be required to complete a pre-employment medical assessment.
Please note this site is not accessible via public transport.
Applicants must have reliable private transport to travel to and from the site.
Key Responsibilities
Execute CSV activities for standalone and enterprise systems
Support the lifecycle management of manufacturing, packaging, and computerised systems
Develop and execute validation requirements for new equipment, systems, and upgrades
Prepare, review, and maintain validation documentation including protocols, reports, and risk assessments
Provide technical support for system changes,



improvements, and compliance activities
Manage and support computerised systems projects across the site
Collaborate with local and global stakeholders on system validation initiatives
Support continuous improvement projects across Production and Packaging operations
Assist with the assessment, implementation, and validation of new equipment and systems
Ensure compliance with GMP, company procedures, data integrity requirements, and health & safety standards
Skills & Experience
Bachelor's degree in Science, Engineering, Information Technology, or a related discipline
Previous experience within the pharmaceutical, biotechnology, medical device, or other regulated manufacturing industries
Experience with CSV, validated systems, and/or GAMP 5 methodologies
Experience preparing and maintaining validation documentation including validation plans, protocols, and reports
Understanding of GMP requirements, data integrity principles, and regulated manufacturing environments
Experience working with manufacturing, packaging, automation, SCADA, MES, ERP, or other computerised systems is highly regarded
Strong problem-solving, project management, and stakeholder engagement skills
3-5+ years' experience in CSV, validation, engineering, quality systems, automation, or regulated manufacturing environments is highly regarded
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📌 Computerised Systems Validation Specialist (Queensland)
🏢 Evolve Scientific
📍 Queensland