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Senior Validation Associate

CSL

Location: Parkville

Job Type: Full time

Posted


Job Description

The Opportunity

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.

The Role

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

About Us

Our Benefits

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 Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!