Vivek Yadav — Associate Consultant
The Automation Struggle Is Real. You kick off a new automation project. The scope looks clear. The tech stack is solid. But then the real work begins… Managing and handling different scopes of work seems tough and even worse when you are not sure about that. You started execution but you need support and helping hands. I help teams design, execute, and validate automation in a way QA, engineering, and operations can all stand behind. With hands-on experience across multiple platforms and standards like GAMP5 and 21 CFR Part 11, I help clients overcome challenges such as inconsistent documentation, inefficient control systems, and regulatory risks. What I’m typically brought in for • Automation projects where GAMP5 and 21 CFR Part 11 aren’t optional • Plants dealing with inconsistent URS/FRS/FDS/SDS documentation • OEM or SI projects where scope creep and unclear ownership are killing timelines • FAT/SAT cycles that turn into firefighting exercises: Especially when FATs pass on paper (but everyone knows SAT is where things usually unravel.) • Teams preparing for audits who don’t want last-minute validation chaos How I help • End-to-end automation documentation aligned with GAMP5 • System architecture & kick-off planning that prevents downstream surprises • PLC & SCADA design across multiple platforms • FAT & SAT execution that actually reflects real-world use • MES integration for digital manufacturing environments • CSV validation & equipment qualification (21 CFR Part 11 compliant) • QA-aligned change management under cGMP & SOP frameworks • Technical Documentations, Onsite & Remote Support and Technical Trainings. Everything is built to be auditable, traceable, and supportable — not just “working”. Who this is for: If you’re responsible for an automation project where failure means audit risk, delays, or rework, and you want a partner who understands both engineering reality and regulatory pressure — that’s where I operate. 📩 DM me or connect if you want to simplify automation without guessing, scrambling, or fixing it twice. 🤝 Let’s Collaborate.
Stackforce AI infers this person is a specialist in Industrial Automation with a focus on compliance and system integration.
Location: Prayagraj, Uttar Pradesh, India
Experience: 15 yrs 9 mos
Skills
- It Integration
- Ge Cimplicity
- Project Management
- Solution Architecture
- Computerized System Validation
- Hmi Programming
Career Highlights
- Expert in GAMP5 and 21 CFR Part 11 compliance.
- Proven track record in managing complex automation projects.
- Strong background in MES and SCADA system integration.
Work Experience
Atos
Consultant (4 yrs 5 mos)
NexCity Solutions
Engineering Project Manager (1 yr 3 mos)
Teva API India Limited
Sr. Engineer -Engineering (2 yrs 10 mos)
Lupin Ltd
Executive Engineer - Projects / Maintenance (3 yrs 10 mos)
IAB Automation
Sr. Engineer (3 yrs)
Rockwell Automation
Graduate Engineering Trainee (1 yr 1 mo)
Education
Bachelor’s Degree at ABES Engineering College