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System Validation Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeSystemValidation Full time $100,000 - $140,000
Job Title: System Validation Specialist

A leading company in the pharmaceutical and medical device industries seeks a skilled professional to join their team as a system validation specialist.

About the Role

We are looking for an experienced individual with a strong background in computer system validation (CSV) to work on cutting-edge advanced therapeutics facilities based in Australia's largest health, education, research, and innovation precinct.

This full-time opportunity is ideal for someone who has a strong knowledge of GAMP 5, data integrity, and relevant regulatory frameworks and is passionate about making a meaningful impact in a high-growth setting.

The ideal candidate will have experience validating ERP, LIMS, QMS, or equipment-related software and be comfortable working flexibly to meet production schedules.


Key Responsibilities
  • 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

3+ years' experience in CSV in 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

Comfortable working flexibly to meet production schedules


What We Offer

You'll join a values-driven team pushing the boundaries in therapeutic manufacturing – with plenty of room to grow, innovate, and shape the future of health.

We invest in your future, commit to hands-on certifications, and offer professional training.

Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.