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 environment.
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 ***** 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.
Robust 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 collaborative, 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.
#J-*****-Ljbffr

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