System Validation Expert

2 days ago

Sydney, New South Wales, Australia beBeevalidation Full time $90,000 - $120,000

As a CSV Specialist, you will be part of a cutting-edge team in Australia’s largest health precinct. Your primary responsibility will be to lead validation activities across GxP-regulated systems.

This role requires strong knowledge of data integrity, relevant regulatory frameworks, and hands-on experience validating ERP, LIMS, QMS, or equipment-related software.

You will work closely with IT, QC, and business teams to meet user and regulatory needs, ensuring compliance with FDA 21 CFR Part 11 and EU Annex 11.

Your expertise in CSV within GxP environments will be invaluable in contributing to data integrity programs, supporting audits, training staff, and promoting a quality-focused culture.

The ideal candidate should have:

  • At least 3 years of experience in CSV in pharma, biotech, or medical devices
  • Strong analytical skills and attention to detail
  • Excellent communication and teamwork skills

About the role:

This is an exciting opportunity to join a values-driven team that is pushing the boundaries in therapeutic manufacturing. You will have the chance to make a real impact and contribute to the company's success.

The successful candidate will have a strong background in CSV and excellent problem-solving skills. If you are passionate about delivering high-quality results and working collaboratively, this could be the perfect role for you.

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