Senior Validation Associate
Job Type: Full time
We are looking for a Senior Validation Associate to join 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.
Based at Tullamarine and reporting to the Validation Manager, in this full-time fixed term role ending in December 2024 you will provide initial qualification, re-evaluation and re-qualification support for the design, start up, commissioning and qualification of equipment (including associated computer systems, facilities, and utilities), manufacturing and cleaning processes according to project timelines.
In this interesting role you will:
- Provide ownership for established validation programs for specific validation area;
- Ensure appropriate standards of cGMP, housekeeping, Health Safety and Environment are applied within validation, following current regulations and procedures;
- Complete major / critical deviation investigations and validation assessments following cGMP and site procedures;
- Provide training in core validation concepts and complex validation processes to new validation team members;
- Be a Subject Matter Expert during regulatory inspections;
- Lead 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;
- 5+ years' experience in the Pharmaceutical Industry in a validation, quality assurance or engineering related role;
- 5+ years' experience applying validation protocols to systems, processes, cleaning and equipment;
- Demonstrated knowledge of GMP, QMS and Risk Management;
- Experience in a role requiring cross functional collaboration;
- 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-184554 by November 29, 2022
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