Scientific IT & Data Validation Specialist

BioAgilytix Labs, LLC; City of Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

360biolabs in Australia is seeking an IT Validation Specialist to provide IT and application support for scientific software, with emphasis on CSV activities and validation documentation.

You will perform spreadsheet validation, develop validation protocols, and maintain SOPs while liaising with stakeholders to ensure compliant, traceable validation across the lifecycle of laboratory software.

Qualifications

• Degree in Science or IT or equivalent plus relevant experience (Essential)
• Experience in writing computer system test scripts, validation protocols and summary reports (Essential)
• Experience in technical writing in both validation and QMS documentation (Essential)
• Good interpersonal skills to facilitate interaction among staff and project teams (Essential)
• Ability to work independently on multiple concurrent projects with minimal guidance (Desirable)

Responsibilities

• Be actively involved in performing Computer Systems Validation activities, particularly with spreadsheets validation as according to the spreadsheet validation SOP.
• Create, update and/or review validation documents including but not limited to spreadsheet/user requirements, test plans, IQ/OQ/PQ tests, UAT and reports.
• Writing and reviewing validation documentation that meet regulations and requirements, including change management activities.
• Facilitate and conduct functional risk assessments.
• Liaise with stakeholders (vendors, subject matter experts, testers) in the planning and execution of CSV projects.
• Where required, prepare spreadsheet templates and validate their use according to SOP.
• Review spreadsheet templates if prepared by others and assist in validating their use.
• Be involved in maintaining validation of computerised systems and spreadsheets.
• Assist in maintaining Computer Systems Validation SOPs and Templates.
• Must be highly proficient with the use of Excel, particularly with formulas, functions and protecting spreadsheets.
• Provide application support for a wide range of scientific applications.
• This includes covering the entire lifecycle of application systems, from strategy through to support and retirement.
• Be involved in investigating, analysing hardware and software problems, and ensuring relevant validation documentation are updated.
• Contribute towards scientific system upgrades, installation, integration, customisation and configuration, and ensure validation documents are updated accordingly
• Maintain effective communication with users when resolving incidents and fulfilling requests

Skills

Analytical skills

Problem solving

Attention to detail

Communication

Organisational skills

Team collaboration

Self-motivation

Education

Degree in Science or IT or equivalent

Tools

Excel

LIMS

Document Management Systems

Job description

360biolabs in Australia is seeking an IT Validation Specialist to provide IT and application support for scientific software, with emphasis on CSV activities and validation documentation.

You will perform spreadsheet validation, develop validation protocols, and maintain SOPs while liaising with stakeholders to ensure compliant, traceable validation across the lifecycle of laboratory software.