Validation Associate

The Opportunity

Come and bring your validation knowledge to our growing Project Banksia team constructing our advanced Influenza cell-culture (FCC) manufacturing facility in Tullamarine (Victoria, Australia). Expected to be completed in 2026, this facility will be 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, known as Products of National Significance (PNS).

Based on-site at Tullamarine and reporting to the Validation Manager, in this full-time fixed term role ending in June 2025, you will support the initial qualification, re-evaluation and re-qualification support for the design, start up, commissioning and qualification of equipment, manufacturing and cleaning processes according to project timelines for the PNS portfolio.

The Role

As the Validation Associate, you will:
- Support established validation programs for the PNS portfolio for equipment, associated computer systems, facilities, and utilities and PNS manufacturing and cleaning processes;- Help ensure appropriate standards of cGMP, housekeeping, Health Safety and Environment are applied within validation, following current regulations and procedures;- Participate in major / critical deviation investigations and validation assessments following cGMP and site procedures;- Help prepare documentation for regulatory inspections and participate in any audits;- Participate in innovation or improvement projects and highlight innovations in validation processes and procedures.

Your skills and experience

To be considered for this role you have:
- A bachelor's degree in an Engineering or Science related field;- 3+ years' experience in the Pharmaceutical Industry in a validation, quality assurance or engineering related role;-
- Demonstrated knowledge of GMP, QMS and Risk Management;- Experience communicating complex information including experience in technical writing;- Experience in a role requiring mechanical aptitude.

How to apply: Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-200110 by 10th of April, 2023.

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

you can participate in when you join CSL Seqirus.

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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