The Role
Join a dynamic pharmaceutical manufacturing environment where you will take ownership of Computerised Systems Validation and IT infrastructure qualification across the site. This is a rare opportunity to work independently, apply your expertise broadly and influence how compliant digital systems are governed throughout their lifecycle.
You will play a central role in modernising and digitising CSV practices, strengthening risk-based assurance and helping shape a future-ready validation framework. Working closely with Quality, IT, Engineering and system owners, you will have the scope to drive meaningful improvement while ensuring systems, infrastructure and electronic records remain compliant, reliable and fit for intended use.
About Mayne Pharma
Mayne Pharma is a global pharmaceutical company offering end-to-end pharmaceutical development and manufacturing to customers around the world. Our heritage makes us one of the most well-known and respected pharmaceutical companies in Australia.
Mayne Pharma Australia are passionate about bringing globally valued pharmaceuticals to Australian patients and consumers. Our values of Passion, Integrity, Accountability, Creativity, Empowerment and Agility are the foundation for everything we do.
Why Join Us?
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Attractive remuneration packages
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Professional Development
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Mayne Perks: Enjoy exclusive discounts and savings
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Community Service
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Recognition and Team Events
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Exclusive Health Insurance Benefits
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Well-being Programs
Here’s where you come in!
Your responsibilities, at a glance, will include:
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Lead and manage the site's Computerised Systems Validation (CSV) and IT Infrastructure Qualification programme, ensuring GxP computerised systems remain validated and compliant throughout their lifecycle.
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Develop, review and approve validation documentation including validation plans, risk assessments, specifications, protocols, reports and supporting evidence for GxP computerised systems.
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Assess change controls, system upgrades, patches and infrastructure changes to determine validation impact and revalidation requirements.
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Maintain the validated state of GxP computerised systems through effective lifecycle management, data integrity controls, periodic review, supplier oversight and compliance monitoring.
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Provide expert CSV, data integrity and IT qualification advice, training and inspection support while collaborating with Quality, IT, Engineering, Operations and external service providers.
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Perform other duties considered appropriate for the position, as required.
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Additionally, collaborate with cross-functional teams within Mayne Pharma's production facility in Salisbury, South Australia, and external technology, engineering and quality partners.
You need to tick these boxes
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We pick applicants based on capability and aptitude. But we also emphasise cultural fit. Therefore, you'll need to have a positive mindset and be prepared to take ownership of your performance.
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You'll also need to hold a degree or equivalent qualification in Information Technology, Engineering, Science, Quality or a related discipline. You will have significant experience in Computerised Systems Validation (CSV), software assurance or IT infrastructure qualification within a regulated GxP environment, together with strong knowledge of data integrity, validation principles, electronic records, quality risk management and supplier oversight.
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You will be able to independently manage validation programmes, compliance risks and multiple priorities while demonstrating excellent technical writing, analytical and stakeholder management skills.
Ready to become part of the Mayne Pharma story?.
How To Apply - Click the APPLY NOW button
