The Opportunity

A full-time fixed-term position until 30 June 2025 has become available for a Lead Computer System Validation (CSV) Engineer to join our growing project Banksia team for the construction of our new manufacturing site in Tullamarine (Melbourne, Australia). Expected to be completed in 2026, this site will house the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere and will also produce unique products important to Australia’s public health needs such as snake and spider antivenoms.

You will ensure all computerised systems used to support Good Manufacturing Practice (GMP) operations for the manufacture, filling and packaging of life saving medicines are validated and controlled.

The Role

Reporting to the APAC CSV Lead, you will:

- Work with local and global CSV and project qualification and quality assurance teams to build agreement of validation expectations.
- Document the agreed validation expectations in jointly approved validation strategy/validation master plans
- Work with project execution systems team to ensure the oversight of CSV activities associated with the project
- Provide support of change management processes in collaboration with Quality
- Oversee the preparation, delivery, and execution of factory and site acceptance testing according to the vendor’s approved Quality Management System
- Oversee the preparation, delivery, and execution of CSV owned validation protocols
- Manage the System Development Lifecycle and maintaining the validated the state of computerised systems
- Oversee Data Integrity Assessment execution and help with periodic review assessments

Your skills and experience
- Bachelor's in Engineering, Computer Sciences, or similar field
- 5+ years' experience with CSV methodologies in pharmaceutical and biotechnology industries
- Experience with regulations such as PIC/S Annex 11, Annex 15 and 21 CFR Part 11
- Experience in writing, reviewing and executing CSV qualification documents (IQ, OQ, PQ)
- Experience in CSV inspection readiness preparations and supporting regulatory agency inspections
- Understanding of industry guidelines related to computerised systems like GAMP5
- Knowledge of Software Development Lifecycle (SDLC) model and a risk-based approach to validation of computerised systems

How to apply

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the

benefits

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About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL

Seqirus


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