CSV and CQV
Validation strategy, requirements, test evidence, traceability, and practical delivery across computerised manufacturing and lab systems.
Niall O'Rourke
CSV Lead Engineer and pharmaceutical validation specialist building practical AI in Pharma tools for document review, URS generation, Part 11 readiness, and evidence-led validation work.
- Role
- CSV Lead Engineer
- Base
- Ireland
- Focus
- CSV, validation, AI in Pharma
Validation thinking, AI in Pharma, and clear regulated documentation.
Useful work at the edge of validation and AI in Pharma.
The site is built around the public topics people are most likely to search for: regulated systems, evidence, validation language, and practical AI support for pharma teams.
Part 11 and Annex 11
Electronic records, electronic signatures, audit trails, access controls, data integrity, and validation lifecycle expectations.
Automation systems
Plant-floor context across DCS, SCADA, PLC, historian, vision, inspection, packaging, and supporting infrastructure.
AI in Pharma tooling
Proof-of-concept AI workflows for first-pass document review, AI URS generation, evidence extraction, and review consistency.
Featured book
Practical Guide to 21 CFR Part 11
A practical guide for electronic records, electronic signatures, and data integrity decisions.
A practical handbook for navigating electronic records, electronic signatures, data integrity, and Part 11 implementation questions. The page is ready for cover artwork and the Amazon link when they are available.
Practical Guide21 CFR Part 11Cover artwork coming soon
Selected work
Public projects and proof-of-concept tools connected to validation, compliance education, and AI in Pharma workflows.
P11Education
Part11Compliance.com
A public learning hub for Part 11 concepts, compliance explanations, workflow demos, and search-friendly validation resources.
Open projectPGProof of concept
ProtonGlow
An AI-enabled concept tool for generating structured user requirements specifications in regulated environments.
Open projectVGProof of concept
VeracityGXP
An AI document review concept focused on traceable findings, validation wording, and GxP-aware review support.
Open projectBuilt in real manufacturing environments.
Public professional history across pharmaceutical validation, commissioning, automation, inspection, and regulated documentation.
Amgen
Computerised Systems Validation Lead EngineerCSV lead work for aseptic filling and inspection lines, validation strategy, documentation oversight, and AI-assisted first-pass validation review.
Amgen
Computerised Systems Validation EngineerAutomation and qualification work across SCADA, inspection, SQL Server, PLC, ThinManager, freeze dryer, syringe inspection, and packaging systems.
WuXi Vaccines
Computerised Systems Validation EngineerCommissioning and qualification of computerised systems for a start-up vaccines manufacturing site.
AbbVie
CSV / CQV EngineerDeltaV, IOQ, FAT, SAT, loop checks, OQ, PQ, validation plans, protocols, summary reports, RTMs, and SOP updates.
Writing and resources
Clear public explanations for validation teams, quality engineers, and people learning how regulated systems actually work.
Part 11 practical guidance
Clear explanations for validation teams working through electronic records, electronic signatures, audit trails, and data integrity.
Pharmaceutical validation terminology
Plain-English validation and GxP terminology for engineers, quality teams, and people learning the discipline.
AI in Pharma workflows
Practical thinking on how AI-assisted review and generation tools should be bounded, checked, and evidenced.
Start with the public profile.
For validation, Part 11, AI in Pharma, writing, or collaboration enquiries, LinkedIn is the best public starting point.