Computer Systems Validation (CSV) Engineer (Biotech)

TL;DR

Computer Systems Validation (CSV) Engineer (Biotech): Planning, writing, and reviewing validation protocols for computer-based systems with an accent on regulatory compliance and system integrity. Focus on executing IQ, OQ, and PQ protocols and ensuring systems meet strict industry standards.

Location: Melbourne, Australia

Company

A biotech consultancy specializing in computer systems validation and regulatory compliance.

What you will do

• Write, review, and approve validation procedures, test scripts, and final reports in compliance with regulatory standards.
• Maintain accurate validation documentation.
• Analyze validation data and compile detailed reports.
• Recommend and implement process upgrades to improve efficiency.
• Support internal audits and external inspections.

Requirements

• Bachelor’s Degree in Computer Science, Engineering, or equivalent experience.
• 2-5 years of experience in computer systems validation (CSV).
• Experience writing and executing IQ, OQ, PQ, RTM, Test Scripts, and Summary Reports.
• Strong attention to detail and ability to follow strict protocols.
• Excellent written and oral communication skills.

Nice to have

• Knowledge of operating systems and MS Office.
• Broad knowledge of regulatory, compliance, and validation frameworks.