Computerised Systems Validation Specialist

Evolve Scientific; Ipswich City; On-site; AUD 110,000 - 170,000; Full time

Job summary

Evolve Scientific is seeking a Computerised Systems Validation Specialist to support validation across Production and Packaging in a GMP-regulated environment. You will manage validation lifecycle for computerised systems and equipment, working with cross-functional teams on implementations and upgrades.

The role requires a strong background in CSV, GAMP 5, and data integrity, with a focus on ensuring systems remain fit for purpose and compliant across manufacturing operations.

Qualifications

• Bachelor’s degree in a relevant science/engineering field.
• 3–5+ years in CSV/validation within regulated manufacturing.
• Experience with GMP, data integrity, and validation documentation.
• Experience with CSV, validated systems, and GAMP 5 procedures.

Responsibilities

• Execute CSV activities for standalone and enterprise 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

CSV experience

GAMP 5 knowledge

Data integrity

Stakeholder engagement

Project management

Problem solving

Education

Bachelor’s degree in Science/Engineering/IT

Tools

SCADA

MES

ERP

Job description

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 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 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