ENT‑001 / INDUSTRIAL ARCHITECTURE
Vikas Phatak
RUNNINGSenior MES & Industrial Automation Engineer
I design enterprise automation systems that turn regulated pharmaceutical manufacturing into software you can trust, delivering electronic batch records, GxP compliance, and audit trails built to withstand rigorous inspection.
- EXP
- 15 yr+
- DOM
- Pharma / GxP
- STD
- ISA-88/95
- STK
- .NET · Python · React · AI Agents
Experience
Domain
Standards
Core stack
What I build
Core competencies across regulated manufacturing, control systems, and enterprise data pipelines.
U-101
MES & Electronic Batch Records (eBR)
Architecting and configuring enterprise eBR and digital recipe workflows across regulated pharmaceutical lines. Implementing review-by-exception, automated parameter verification, and 21 CFR Part 11 compliant electronic signatures.
U-102
GxP Compliance & Computer Systems Validation
Delivering systems aligned with GAMP 5 principles, EU GMP Annex 11, and 21 CFR Part 11 from the substrate up. Leading risk-based Computer Software Assurance (CSA), URS/FRS design, and end-to-end traceability.
U-103
Shop Floor IT/OT & Automation Integration
Bridging Level 2 control systems (PLCs, SCADA, DCS) with Level 3 MES and Level 4 SAP ERP. Building resilient OPC-UA, MQTT, and RESTful data pipelines for real-time batch historian tracking and material flow.
U-104
ISA-88/95 Equipment Modeling & AI Workflows
Structuring plant hierarchies and batch control models to ISA-88/95 standards. Leveraging automated AI agent workflows to streamline engineering documentation, test case generation, and audit log verification.
Writing & work
One engine, several exhausts. The thinking, the book, and the code.
- PUB-01 Agent-Driven Blog Engineering Dispatches Technical deep-dives and field notes on autonomous AI agent orchestration, MES architecture, and industrial systems. Published autonomously by the agent workflow engine. Read dispatches
- PUB-02 Publication Validated State Field notes on MES architecture and regulated manufacturing — the design decisions behind systems that pass audit. Read the publication
- REPO-01 GitHub Open source & Agent Workflows Equipment libraries, DTDL model generators, and the autonomous Python orchestration engine behind this blog. Built in the open. Browse the repos
Active Channels
Dispatches and field notes on MES & regulated manufacturing.