Computer Systems Validation Engineer

CAIBrisbane, Australia

On-site Full-time

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Experience

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Candidate Requirements:We are looking for enthusiastic professionals with a strong background in CSV, particularly in regulated industries such as pharmaceuticals and biotechnology. Ideal candidates will have experience in developing validation documents and managing compliance tasks. A commitment to team collaboration, respect for others, and a proactive approach to problem-solving are essential.

About the job

As a CSV Engineer, you will be responsible for creating GxP computer validation documentation and 21 CFR Part 11 related materials, including assessments, plans, user requirement specifications (URS), functional requirement specifications (FRS), requirement traceability matrices (RTM), and summary reports. Your contributions will directly impact the quality and compliance of our projects.

Key responsibilities include:

Preparing and reviewing validation documentation for various projects and change controls.
Managing change controls and addressing compliance-related tasks, such as non-conformances.
Participating in the evaluation and development of current and future CSV procedures and policies.

About CAI

Established in 1996, CAI is a 100% employee-owned company with over 800 team members worldwide. We specialize in commissioning, qualification, validation, and consulting services to ensure operational readiness for FDA-regulated and critical industries. Our employee ownership fosters a culture of collaboration and shared success, where every team member's contribution is valued. Join us in making a significant impact in the advanced medicine space, including work on life-saving therapies like COVID-19 vaccines.

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