Janani Sathish
Computer System Validation & Testing Expert | 11+ Years in GxP, 21 CFR Part 11, EU Annex 11, GAMP 5 | Validation Lifecycle Management, Regulatory Compliance & Stakeholder Engagement
- Role
- Csv Lead at Thermo Fisher Scientific
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Janani Sathish
Have you ever thought about how the medicines you take or the tech behind them get checked to keep you safe? Well, those big pharma companies that seemed super far away now trust me to make sure their systems work perfectly—and it feels amazing!I’m Janani Sathish, a Computer System Validation (CSV) pro with over 11 years of experience. I started small in Chennai, learning hands-on while juggling studies, and now I help huge companies pass tough tests like FDA audits. I’ve grown to lead validation projects that meet strict standards like 21 CFR Part 11, EU Annex 11, and GAMP 5—making a real impact on patient safety and innovation.It’s not magic—it’s hard work and a love for getting things right!Picture this: I began with basic testing jobs, then climbed up to lead teams, write super-important documents, and even earn awards like the GEM (Going Extra Mile) from Navitas Life Sciences. I’ve checked over 30 processes in just 6 months for a big client and got a shoutout from the FDA for my work. Cool, right?Here’s my story twist: I came from a simple background, studied electronics in college, and went abroad to learn more. I didn’t let where I started stop me—my effort and focus on quality did the trick! Now, I work remotely for companies like Thermo Fisher Scientific, guiding teams and making sure everything runs smoothly.So, why should you care? In today’s world, tech and safety go hand-in-hand, and people like me make sure it all works. You’re just one step away from chasing your dreams—whether it’s tech, science, or something else! I can help you see how skills and persistence pay off.My goal? To inspire others and keep solving problems that matter. I don’t just check systems—I build trust and protect people’s health. But it bugs me to see talented folks stay unnoticed because they don’t know how to shine.Your move: Keep dreaming big or start standing out like I did! I promise to share my know-how to help you grow—no pressure, just support.Ready to learn or connect? DM me here on LinkedIn Email: j••••••••@live.com Let’s chat about your goals!
Experience
Csv Lead
Jun 2025 — Present
Education
Sri Venkateswara College of Engineering
Bachelor's Degree, Electronics and Communication Engineering
2007 — 2010
University of Nottingham Malaysia Campus
Master's Degree, Electronics Communication and Computer Engineering
2011 — 2013
Sri Sai Ram Polytechnic College
Engineer's Degree, Electronics and Communication Engineering
2004 — 2007
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