Niall O’Rourke is a Computerised Systems Validation (CSV) and Commissioning, Qualification, and Validation (CQV) Engineer with extensive experience across biologics, small molecule, and drug product manufacturing.

Over the past several years, he has worked on large-scale pharmaceutical projects for leading companies including Amgen, AbbVie, and WuXi Vaccines, supporting new facility startups and the qualification of computerized systems such as DeltaV DCS, GE iFIX, Systech Vision Systems, and Siemens/Allen-Bradley PLC platforms.

He is the author of Practical Guide to 21 CFR Part 11, and the creator of Part11Compliance, a learning platform dedicated to helping validation and QA professionals understand 21 CFR Part 11 requirements.

Niall’s teaching style is practical, example-driven, and grounded in real-world project experience. His goal is to help engineers and quality professionals write IOQ protocols that are clear, compliant, and audit-ready, while reducing rework and improving efficiency across projects.