Computer Systems Validation (CSV) & Scientific Systems Specialist

Bayside Group; City of Melbourne; On-site; AUD 120,000 - 130,000; Full time

Job summary

Bayside Group has partnered with a Melbourne-based organisation to recruit a CSV & Scientific Systems Specialist. The role blends hands-on validation with ongoing support for scientific applications in a highly regulated environment.

You will work across CSV, user requirements, test scripts, and validation reports, ensuring systems stay validated while assisting with troubleshooting and system changes. Strong Excel/VBA and written documentation are essential.

Qualifications

• Direct experience validating computerised systems within a regulated environment.
• Experience writing computer system test scripts, validation protocols and summary reports.
• Strong technical writing capability across validation and quality documentation.
• GxP knowledge and regulations applicable to computerised systems (e.g., 21 CFR Part 11, GLP).

Responsibilities

• Performing Computer Systems Validation across regulated computerised systems
• Preparing, reviewing and executing user requirements, test plans/scripts, IQ/OQ/PQ, UAT and validation reports
• Conducting functional risk assessments and supporting change management activities
• Maintaining computerised systems and spreadsheets in a validated state
• Providing ongoing support for scientific and laboratory applications
• Investigating software and hardware issues and supporting incidents and user requests
• Supporting system upgrades, installations, integrations, configuration and customisation while keeping validation documentation current
• Working closely with scientific users, Quality, IT, vendors, SMEs and other stakeholders

Skills

CSV validation

GxP knowledge

Regulated spreadsheets

Excel VBA

Technical writing

Root cause analysis

Stakeholder communication

Lab software support

Education

Bachelor's degree in Science or IT

Tools

LIMS

Excel

Windows Server

Job description

Computer Systems Validation (CSV) & Scientific Systems Specialist

If your experience sits between Computer Systems Validation and scientific applications, this is a strong opportunity to combine both in one permanent role.

Bayside Group is partnering with an established organisation operating within a highly regulated scientific environmentto recruit a Computer Systems Validation (CSV) & Scientific Systems Specialist.

This is not a purely documentation-based validation position, and it is not a traditional IT support role.

You will work across the validation and ongoing lifecycle support of scientific computerised systems, combining hands-on CSV with application troubleshooting, system changes, user support and regulated spreadsheet validation.

Permanent Full-Time | Melbourne | On-site
$120,000–$130,000 + super

Working within the Information Systems function, you will support a range of scientific applications throughout their lifecycle while ensuring systems remain appropriately validated and compliant.

Your responsibilities will include:

• Performing Computer Systems Validation across regulated computerised systems
• Preparing, reviewing and executing user requirements, test plans/scripts, IQ/OQ/PQ, UAT and validation reports
• Conducting functional risk assessments and supporting change management activities
• Maintaining computerised systems and spreadsheets in a validated state
• Preparing, reviewing and validating controlled Excel spreadsheets and templates, including formulas, functions, protection and version control
• Providing ongoing support for scientific and laboratory applications
• Investigating software and hardware issues and supporting incidents and user requests
• Supporting system upgrades, installations, integrations, configuration and customisation while keeping validation documentation current
• Working closely with scientific users, Quality, IT, vendors, SMEs and other stakeholders
• Contributing to validation procedures, templates and continuous improvement activities

We are looking for someone with genuine Computer Systems Validation experience who is also comfortable working hands-on with scientific applications and their users.

You will ideally bring:

• Direct experience validating computerised systems within a regulated environment
• Experience writing computer system test scripts, validation protocols and summary reports
• Strong technical writing capability across validation and quality documentation
• Knowledge of GxP and regulations applicable to computerised systems, including 21 CFR Part 11 and GLP
• Experience within pharmaceutical, biotechnology, laboratory, CRO or another regulated scientific environment
• Exposure to LIMS, document management systems or other scientific/laboratory software
• Experience supporting applications after implementation, including troubleshooting and resolving user issues
• Strong Microsoft Excel capability and experience or understanding of regulated spreadsheet validation
• Working knowledge of Windows desktop and server environments
• Strong analytical and root cause problem-solving skills
• The ability to manage multiple priorities independently and communicate effectively across technical and non-technical stakeholders

Experience with Excel macros or VBA would be advantageous.

A degree in Science or IT, or equivalent qualification, together with relevant experience, is required.

The attraction of this role is its breadth.

You will not be limited to producing validation documentation. You will work directly with scientific systems and their users, supporting applications throughout their lifecycle while maintaining the validation and compliance framework around them.

For someone whose background sits across CSV, laboratory systems and scientific application support, this offers genuine ownership across both the technical and compliance sides of the environment.

Salary: $120,000–$130,000 + super, depending on relevant experience.