Therapeutic Manufacturing Validation Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeValidator Full time $80,000 - $150,000
About the Role

We are seeking an experienced validation professional to lead validation activities for GxP-regulated systems in a cutting-edge advanced therapeutics facility located in Australia's largest health, education, research, and innovation precinct.

Job Description:

This is a hands-on opportunity for a CSV specialist with strong background in validating ERP, LIMS, QMS, or equipment-related software within GxP environments. The ideal candidate will have experience working flexibly to meet production schedules and be comfortable traveling to different locations as needed.

  • Lead validation activities (IQ/OQ/PQ) across GxP-regulated systems;
  • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5;
  • Partner with IT, QC, and business teams to meet user and regulatory needs;
  • Author and review validation plans, risk assessments, and traceability matrices;
  • Contribute to data integrity programs and support audits;
  • Train staff and promote a quality-focused culture;
Requirements

To succeed in this role, you must have:

  • At least 3 years of experience in CSV within pharma, biotech, or medical devices;
  • Strong knowledge of GAMP 5, data integrity, and relevant regulatory frameworks;
  • Experience validating ERP, LIMS, QMS, or equipment-related software;
  • Detail-oriented, analytical, and proactive team player skills;
  • Australia/New Zealand PR or citizenship status.
Why Join Us?

You'll join a dynamic team that values innovation, collaboration, and excellence in therapeutic manufacturing. As a CSV specialist, you'll have opportunities to grow, innovate, and shape the future of healthcare.

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