_{30th July, 2025}

Job Title: Computer Systems Validation (CSV) Analyst

Location: Greater Sydney area - 3 days onsite, 2 days remote
Contract Type: 12-month contract with extension
Start Date: Immediate

About the Role
A highly regarded organisation in the scientific and technical sector is seeking an experienced and motivated CSV Analyst to support the validation of IT systems used in regulated environments. This role is ideal for a detail-oriented professional who thrives in a structured, compliance-driven setting and is confident engaging with both technical teams and business stakeholders.

Key Responsibilities

Develop and execute validation deliverables including:

• Validation Master Plans
• User Requirement and Functional Specifications
• Risk Assessments and Traceability Matrices
• Installation (IQ), Operational (OQ), and Performance Qualification (PQ) protocols
• Validation Summary Reports
• Plan and facilitate validation activities throughout the system development lifecycle
• Ensure systems are implemented and maintained in a validated state in accordance with GAMP 5, GMP, and regulatory requirements (e.g. 21 CFR Part 11)
• Engage with stakeholders across business units to coordinate validation efforts
• Liaise with vendors to support system setup, documentation, and testing processes
• Support internal teams by providing guidance and training on CSV processes where appropriate

Required Experience and Skills

• Minimum 5 years’ experience in a Computer Systems Validation or similar compliance role
• Experience working with large-scale corporate systems; SAP experience is highly regarded
• Strong understanding of regulatory frameworks (GAMP 5, GMP, PIC/S, FDA 21 CFR Part 11)
• Proven ability to create high-quality validation documentation and manage risk assessments
• Excellent communication and stakeholder engagement skills
• Demonstrated attention to detail and commitment to quality
• Experience in a pharmaceutical, medical devices, or life sciences environment is desirable
• Exposure to Laboratory Information Management Systems (LIMS) is a bonus
• Tertiary qualification in a relevant discipline such as IT, Science, or Engineering

What’s on Offer

• Immediate start in a long-term contract position
• Opportunity to work on high-impact, regulated IT projects
• Hybrid work model: 3 days onsite in South Sydney, 2 days remote
• Professional and collaborative working environment

To express your interest, please submit your CV via the Apply button. For a confidential discussion, reach out to our team after applying.

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