CSV Specialist: GMP Systems Validation & Compliance

Evolve Scientific; Queensland; On-site; AUD 100,000 - 150,000; Full time

Job summary

Evolve Scientific seeks a Computerised Systems Validation (CSV) Specialist to support validation across Production and Packaging in a GMP environment, ensuring systems remain fit for purpose and compliant. You will collaborate with Production, Engineering, Quality and Global teams to implement new systems and upgrades, maintain validation documentation, and drive continuous improvement.

A pre-employment medical assessment is required and private transport is essential for site access.

Qualifications

• Bachelor's degree in Science, Engineering, Information Technology, or a related discipline.
• Experience in pharmaceutical, biotech, 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 GMP requirements and data integrity principles in regulated 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, or related fields.

Responsibilities

• Execute CSV activities for standalone and enterprise systems
• Support 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 assessment, implementation, and validation of new equipment and systems
• Ensure GMP compliance and data integrity across sites

Skills

CSV

Validation lifecycle

GAMP 5

Validation documentation

GMP compliance

Data integrity

Stakeholder engagement

Project management

Manufacturing systems

Regulated manufacturing

Education

Bachelor's degree in Science, Engineering, Information Technology, or a related discipline

Tools

SCADA

MES

ERP

Job description

Evolve Scientific seeks a Computerised Systems Validation (CSV) Specialist to support validation across Production and Packaging in a GMP environment, ensuring systems remain fit for purpose and compliant. You will collaborate with Production, Engineering, Quality and Global teams to implement new systems and upgrades, maintain validation documentation, and drive continuous improvement.

A pre-employment medical assessment is required and private transport is essential for site access.