Validation Specialist

i-Pharm Consulting; City of Melbourne; On-site; AUD 85,000 - 120,000; Full time

Job summary

i-Pharm Consulting is seeking a Validation and IT Support Specialist to provide computer systems validation and application support across scientific platforms within a regulated lab environment.

The role combines validation documentation, spreadsheet validation, stakeholder coordination and day-to-day support, ensuring compliance with GxP, GLP and ISO/IEC 17025 standards.

Qualifications

• Demonstrated experience writing computer-system test scripts, validation protocols and summary reports.
• Strong technical writing experience across validation and quality-system documentation.
• Knowledge of US FDA 21 CFR Part 11 and GLP.
• Advanced Excel formulas, functions, protection and version control.
• IT hardware/software understanding; Windows desktop/server environments.
• Analytical and problem-solving skills including root-cause analysis.
• Excellent organization and attention to detail; manage multiple priorities.
• Collaborative, service-focused communication skills.

Responsibilities

• Perform computer systems validation activities with focus on spreadsheet validation.
• Create, update and review validation documentation (URs, test plans, IQ/OQ/PQ, UAT, traceability, reports).
• Prepare and review validated spreadsheet templates per procedures and version-control.
• Coordinate with vendors, SMEs, testers and business stakeholders.
• Maintain validated state of systems and spreadsheets through change management and upgrades.
• Provide application support for scientific systems and troubleshoot issues.
• Contribute to installations, integrations, upgrades, customization and configuration with proper documentation.
• Follow Quality Management System and GxP/GLP/ISO/IEC 17025 requirements.

Skills

Test scripting

Validation docs

GxP knowledge

Excel capabilities

IT hardware/software

Analytical skills

Organization

Communication

Stakeholder coordination

Education

Degree in Science/Quality/IT

Tools

Windows OS

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 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 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 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.