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System Integration
Software Validation Specialist
Newtown
We seek a detail-oriented and solutions-focused Software Validation Specialist to join our dynamic Systems Integration team. This role plays a critical part in ensuring our diagnostic software, systems, and workflows are validated to the highest standards, supporting regulatory compliance and enabling delivery of reliable, high-quality products to market.
Genetic Signatures improves patient care and outcomes by developing innovative diagnostic technologies that simplify molecular pathology.
We are an Australian-based manufacturer supplying leading clinical laboratories locally and globally, and we are continuing to grow our diverse, supportive and high-performing team.
We are now seeking a detail-oriented and solutions-focused Software Validation Specialist to join our dynamic Systems Integration team. This role plays a critical part in ensuring our diagnostic software, systems, and workflows are validated to the highest standards, supporting regulatory compliance and enabling delivery of reliable, high-quality products to market.
In this role you will be responsible for:
• Executing software validation and verification activities across diagnostic systems and workflows
• Developing and implementing validation strategies aligned with regulatory and lifecycle requirements
• Authoring and maintaining validation protocols, test plans, reports, and traceability documentation
• Analysing validation data, identifying discrepancies, and troubleshooting issues
• Ensuring software meets intended use, specifications, and regulatory standards
• Collaborating with Regulatory Affairs, Product Development, and Technical Support teams
• Supporting investigation and resolution of software-related customer issues
• Contributing to continuous improvement of validation processes and documentation practices
• Assisting in the development of software tools and workflow automation where required
• Supporting compliance with regulatory standards including TGA, IVDR, and other global frameworks
To be successful as our Software Validation Specialist, you will possess:
• Molecular biology experience, including real-time PCR
• Experience in validation of software, products, processes, or equipment in regulated environments
• Strong understanding of quality and regulatory frameworks in diagnostics or life sciences
• Excellent attention to detail and documentation skills
• Strong analytical and problem-solving capabilities
• Effective written and verbal communication skills
• Ability to work both independently and collaboratively across teams
Qualifications & Experience:
• Bachelor’s degree in biomedical science or a related field (Master’s or PhD advantageous)
• Experience in medical devices, diagnostics, or life sciences environments is highly desirable
• Exposure to software validation or assay development is advantageous
Genetic Signatures Ltd is committed to providing equal employment opportunities, we thrive on the diversity of thought that comes to us through our workforce and encourage anyone possessing the talent and drive to better health care for their community to apply.
If you are interested in applying for this role please apply via seek or send your resume and cover letter to [email protected]
If this sounds like your next career opportunity and you want to make a difference to healthcare in communities around the world, apply now, we can't wait to hear from you!
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Equal Employment Opportunity
GSL is committed to providing Equal Employment Opportunity, all applicants with the right talent, qualification and drive will receive consideration for employment without regard to race, colour, religion, national origin, gender, age, sexual orientation, gender identity, disability, status as a Veteran or other protected classification.