Computerised Systems Validation SpecialistAbout the RoleOur 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 environment.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 ResponsibilitiesExecute CSV activities for standalone and enterprise systemsSupport the lifecycle management of manufacturing, packaging, and computerised systemsDevelop and execute validation requirements for new equipment, systems, and upgradesPrepare, review, and maintain validation documentation including protocols, reports,



and risk assessmentsProvide technical support for system changes, improvements, and compliance activitiesManage and support computerised systems projects across the siteCollaborate with local and global stakeholders on system validation initiativesSupport continuous improvement projects across Production and Packaging operationsAssist with the assessment, implementation, and validation of current equipment and systemsEnsure compliance with GMP, company procedures, data integrity requirements, and health & safety standardsSkills & ExperienceBachelor's degree in Science, Engineering, Information Technology, or a related disciplinePrevious experience within the pharmaceutical, biotechnology, medical device, or other regulated manufacturing industriesExperience with CSV, validated systems, and/or GAMP 5 methodologiesExperience preparing and maintaining validation documentation including validation plans, protocols, and reportsUnderstanding of GMP requirements, data integrity principles, and regulated manufacturing environmentsExperience working with manufacturing, packaging, automation, SCADA, MES, ERP, or other computerised systems is highly regardedStrong problem-solving, project management, and stakeholder engagement skills3-5+ 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