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. Available on Amazon in regional stores, with the UK link used as the default.
Selected work
Publications, open standards, and proof-of-concept tools connected to validation, compliance education, and AI in Pharma workflows.
IOQEbook
Writing IQ/OQ Test Protocols
A practical guide to writing executable installation and operational qualification test scripts, with complete worked examples and reusable tables.
Open projectP11Education
Part11Compliance.com
A public learning hub for Part 11 concepts, compliance explanations, workflow demos, and search-friendly validation resources.
Open projectGxPStandards library
GxP Blueprint
An open, versioned standards library for pharmaceutical quality teams and AI agents, with practical SOPs, reusable URS requirements, stable record identities, and public API access.
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 projectFrom plant-floor automation to validation strategy.
A role-by-role history drawn from the current CV, spanning commissioning, automation, inspection, data integrity, and validation leadership.
Amgen
Computerised Systems Validation Lead EngineerLeading validation strategy and documentation oversight for multiple new aseptic syringe filling and inspection lines.
- Change controls, validation plans, system assessments, URS, data integrity assessments, FAT, and IOQ protocols.
- Developed an enterprise AI workflow for first-pass reviews of URS, validation plans, and IOQ protocols.
Amgen
Computerised Systems Validation EngineerDelivered automation-system validation and equipment qualification across aseptic manufacturing and inspection systems.
- Worked across iFIX and InTouch SCADA, Systech vision, SQL Server, Siemens and Rockwell PLCs, FactoryTalk AssetCentre, and ThinManager.
- Supported qualification of freeze dryers, automatic syringe inspection, and packaging lines.
WuXi Vaccines
Computerised Systems Validation EngineerCommissioned and qualified new computerised systems for a start-up vaccines manufacturing site in Dundalk.
- Applied Part 11, Annex 11, GAMP 5, ALCOA+, S88, S95, and data-integrity principles.
- Worked with DeltaV, iFIX, PI, PLCs, virtual infrastructure, VLANs, Active Directory, NTP, NAS, and backup systems.
AbbVie
Computerised Systems Validation EngineerValidated DeltaV software changes, including recipe and code modifications, in a regulated manufacturing environment.
- Authored software URS, validation plans, test protocols, summary reports, and requirements trace matrices.
- Managed TrackWise change controls, updated SOPs, and supported IOQ execution.
AbbVie
CQV EngineerDelivered commissioning and qualification work in small-molecule API and drug-product manufacturing.
- Executed FAT, SAT, IOQ, hardware and I/O checks, loop checks, OQ, and PQ for new manufacturing equipment.
- Coordinated vendors, URS development, permits, RAMS, LOTO, and classified-area controls.
AbbVie
DeltaV Automation InternCompleted an industrial automation placement working with Emerson DeltaV and its connected plant systems.
- Worked with controllers, recipes, modules, iFIX graphics, Profibus I/O, intrinsically safe circuits, PID tuning, PI, OPC UA, and TrackWise.
- Built a reactor temperature-control equipment module and executed the associated IOQ documentation.
Writing and posts
Clear public explanations for validation teams, quality engineers, and people learning how regulated systems actually work.
Read postsPart 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.
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PQ vs PPQ: What Is the Difference?
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