Job Description

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 workplace.

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About the Role

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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 workplace.

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Responsibilities

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- Perform computer systems validation activities, with a strong focus on spreadsheet validation.
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- Create, update and review validation documentation, including user requirements, test plans, IQ, OQ and PQ protocols, UAT scripts, traceability documentation and summary reports.
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- Prepare and review validated spreadsheet templates in line with internal procedures and version-control requirements.
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- Facilitate functional risk assessments and support prospective, concurrent and retrospective validation activities.
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- Coordinate with vendors, subject-matter experts, testers and business stakeholders throughout the validation lifecycle.
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- Maintain the validated state of computerised systems and spreadsheets through change management, upgrades, configuration and retirement.
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- Provide application support for scientific systems, investigate hardware and software issues, and keep users informed through incident resolution.
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- Contribute to system installations, integrations, upgrades, customisation and configuration while ensuring documentation remains current.
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- Work in accordance with the organisation's Quality Management System and applicable GxP, GLP, GCLP and ISO/IEC 17025 requirements.
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Qualifications

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

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

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- Exposure to LIMS, document-management systems or other scientific applications.
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- Experience with Excel macros or VBA.
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- Previous experience within pharmaceutical, biotechnology or another regulated scientific environment.
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- Experience supporting a range of laboratory or scientific software platforms.
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📌 Validation Specialist (Victoria)
🏢 i-Pharm Consulting
📍 Victoria