Computer Systems Validation (Csv) & Scientific Systems Specialist (Melbourne)

Computer Systems Validation (Csv) & Scientific Systems Specialist (Melbourne)

21 Sep
|
Bayside Group
|
Melbourne

21 Sep

Bayside Group

Melbourne

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 setting.
Salary: $120,000–$130,000 + super, depending on relevant experience.
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📌 Computer Systems Validation (Csv) & Scientific Systems Specialist (Melbourne)
🏢 Bayside Group
📍 Melbourne

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