Spreadsheet Validation & IT Support Specialist

360biolabs, a BioAgilytix company; City of Melbourne; On-site; AUD 90,000 - 120,000; Full time

Job summary

360biolabs is a leading Australian quality-accredited specialty lab, part of BioAgilytix, supporting PK/PD assays for clinical trials. We seek an Information Systems professional to support a wide range of scientific applications, ensuring compliance with industry guidelines.

You will perform CSV activities, write validation documents, and collaborate with vendors and stakeholders to maintain system validation and quality management standards.

Qualifications

• Requires a Degree in Science or IT or equivalent with relevant experience.
• Must be highly motivated, able to work independently and prioritise tasks.
• Strong analytical and problem-solving abilities with root-cause analysis.
• Excellent administrative, organisational and communication skills.
• Experience writing computer system test scripts, validation protocols and reports.
• Knowledge of GxP regulations and CSV principles is essential.

Responsibilities

• Perform Computer Systems Validation activities, including spreadsheet validation per SOP.
• Create, update and review validation docs (U/R, test plans, IQ/OQ/PQ, UAT, reports).
• Write and review validation documentation meeting regulatory requirements and change management.
• Conduct functional risk assessments and liaise with stakeholders for CSV projects.
• Maintain validation SOPs and templates; validate spreadsheet templates as needed.
• Provide application support across the lifecycle of laboratory software and systems.

Skills

Self-motivation

Independent work

Analytical skills

Problem solving

Communication skills

Attention to detail

Team collaboration

Willingness to learn

Interpersonal skills

Education

Degree in Science or IT or equivalent

Tools

Microsoft Excel

Windows Server

Windows Desktop OS

LIMS

Document Management Systems

Excel VBA

Job description

360biolabs is a leading Australian quality-accredited specialty lab, part of BioAgilytix, supporting PK/PD assays for clinical trials. We seek an Information Systems professional to support a wide range of scientific applications, ensuring compliance with industry guidelines.

You will perform CSV activities, write validation documents, and collaborate with vendors and stakeholders to maintain system validation and quality management standards.