CSV Specialist: GMP Validation for Manufacturing Systems

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

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.