System Validation Expert

3 days ago

Sydney, New South Wales, Australia Bebeevalidation Full time

We are seeking an experienced Validation Specialist to join our team in a cutting-edge advanced therapeutics facility based in Sydney, Australia.
This is an opportunity for someone with a strong background in Computer System Validation (CSV) within GxP environments, looking to make a meaningful impact in a high-growth setting.
Key Responsibilities
Lead validation activities across GxP-regulated systems, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and 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.
Requirements
3+ years' experience in CSV in pharma, biotech, or medical devices.
Strong knowledge of data integrity and relevant regulatory frameworks.
Experience validating ERP, LIMS, QMS, or equipment-related software.
Australia/New Zealand PR or Citizen.
Why Join?
You'll be part of a values-driven team pushing the boundaries in therapeutic manufacturing – with plenty of room to grow, innovate, and shape the future of health.
This role offers a unique chance to work on cutting-edge projects, develop your skills, and contribute to the success of our organization.
As a member of our team, you'll have access to training and development opportunities, as well as a collaborative and supportive work environment.
We're committed to helping our employees grow professionally and personally, and we offer a range of benefits to support this goal.
In addition to a competitive salary and benefits package, we offer a range of perks and incentives to recognize and reward our employees' hard work and contributions.
We believe that our employees are our greatest asset, and we're committed to providing them with the support and resources they need to succeed.

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