Senior Validation Specialist

3 days ago

Sydney, New South Wales, Australia beBeeValidator Full time

We are seeking an experienced Computer System Validation professional to join a cutting-edge facility based in Australia's largest health, education, and innovation precinct.

This role is ideal for someone with a strong background in CSV within GxP environments, looking to make a meaningful impact in a high-growth, high-integrity setting.

The successful candidate will be responsible for leading validation activities across GxP-regulated systems, ensuring compliance with regulatory frameworks, and partnering with IT, QC, and business teams to meet user and regulatory needs.

Key Responsibilities:

  • Lead IQ/OQ/PQ activities for GxP-regulated systems
  • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5
  • Collaborate with IT, QC, and business teams to meet user and regulatory requirements
  • Develop 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:

  • 3+ years' 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

Why This Role?

You'll have the opportunity to work on cutting-edge technologies in advanced medicine, collaborate with recognized subject matter experts, and contribute to bringing lifesaving therapies to market.

In return, you'll enjoy a collaborative culture, hands-on certifications, and professional training, as well as the chance to grow your career in a high-growth, high-integrity setting.

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