An established scientific organisation is seeking a Validation and IT Support Specialist to provide computer systems validation and application support across a range of scientific platforms. This is a hands-on role combining validation documentation, spreadsheet validation, stakeholder coordination and day-to-day support within a highly regulated laboratory setting.

About the Role

The Validation and Support Specialist will provide computer systems validation and application support across a range of scientific platforms, combining validation documentation, spreadsheet validation, stakeholder coordination and day-to-day support within a highly regulated laboratory environment.

Responsibilities

- Perform computer systems validation activities, with a strong focus on spreadsheet validation.
- Create, update and review validation documentation, including user requirements, test plans, IQ, OQ and PQ protocols, UAT scripts, traceability documentation and summary reports.
- Prepare and review validated spreadsheet templates in line with internal procedures and version-control requirements.
- Facilitate functional risk assessments and support prospective, concurrent and retrospective validation activities.
- Coordinate with vendors, subject-matter experts, testers and business stakeholders throughout the validation lifecycle.
- Maintain the validated state of computerised systems and spreadsheets through change management, upgrades, configuration and retirement.
- Provide application support for scientific systems, investigate hardware and software issues, and keep users informed through incident resolution.




- Contribute to system installations, integrations, upgrades, customisation and configuration while ensuring documentation remains current.
- Work in accordance with the organisation's Quality Management System and applicable GxP, GLP, GCLP and ISO/IEC 17025 requirements.

Qualifications

- A degree in Science, Quality, Information Technology or a related discipline, supported by relevant industry experience.

Required Skills

- Demonstrated experience writing computer-system test scripts, validation protocols and summary reports.
- Strong technical writing experience across validation and quality-system documentation.
- Sound knowledge of computer systems validation principles, GxP expectations and regulations such as US FDA 21 CFR Part 11 and GLP.
- Advanced Microsoft Excel capability, particularly formulas, functions, spreadsheet protection and version control.
- Working knowledge of IT hardware and software, including Windows desktop and server environments.
- Strong analytical and problem-solving skills, including root-cause analysis.
- Excellent organisation, attention to detail and the ability to manage multiple priorities independently.
- A cooperative, service-focused approach with strong written and verbal communication skills.

Preferred Skills

- Exposure to LIMS, document-management systems or other scientific applications.
- Experience with Excel macros or VBA.
- Previous experience within pharmaceutical, biotechnology or another regulated scientific environment.
- Experience supporting a range of laboratory or scientific software platforms.

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📌 Validation Specialist (Melbourne)
🏢 i-Pharm Consulting
📍 Melbourne