Computer System Validation (CSV) Specialist

Job Description

About the Role

We are seeking a hands-on, experienced Computer System Validation (CSV) Specialist to join a cutting-edge advanced therapeutics facility based in Australia’s largest health, education, research, and innovation precinct.

This full-time opportunity 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.

Work Location: Sydney, Australia

Employment Type: Full Time Employee

Requirements include:

·       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.

Position Requirements: 

·       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.

Are you interested in this position?

Apply by clicking on the “Apply Now” button below!

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