Validation Specialist

2 days ago

Sydney, New South Wales, Australia On Q Recruitment Full time $80,000 - $120,000 per year

Are you an experienced Validation Specialist looking to make an impact in a growing organisation? This is a rare opportunity to join an established biotech organistaion at an exciting stage of expansion, where you will play a key role in shaping validation processes and supporting the introduction of new products.

Following a recent restructure, the company is seeking a hands-on validation professional to establish best practices and lead validation activities across R&D, QA, and Production. You will work closely with teams that genuinely collaborate, value open communication, and take pride in delivering high-quality outcomes.

Key Responsibilities

  • Plan and execute validation projects in line with the Validation Master Plan.
  • Develop and review validation protocols, reports, and supporting documentation.
  • Perform risk assessments, gap analyses, and support change control and deviation processes.
  • Coordinate technical transfers between QA, R&D, and Manufacturing.
  • Ensure validation activities meet cGMP, regulatory, and internal SOP requirements.
  • Act as a subject matter expert for validation during audits and inspections.

About You

  • Minimum 3 years hands-on validation experience within pharmaceutical, biotech, or medical device manufacturing.
  • Strong understanding of validation principles, GMP, and regulatory frameworks.
  • Skilled in process and equipment validation, risk assessment, and documentation.
  • Confident communicator who can influence, question processes, and work collaboratively.
  • Able to work independently and produce validation documentation from start to finish.

Why Join?

  • Be part of a supportive and down-to-earth QA team that values initiative and teamwork.
  • Opportunity to take ownership of validation strategy and drive process improvements.
  • Work with a company introducing exciting new products and investing in growth.

If you are ready to step into a high-impact role where your validation expertise will shape future success, I would love to hear from you. This is a full-time position based in the office. For any additional information, please contract Grace Bitodi at or

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