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Manasha Karunanidhi

@manashakarunanidhi

MES Validation Specialist at Capgemini supporting Sanofi's Apprentice MES, with validation work spanning GxP and Athena integration.

India
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At Capgemini, I support validation and functional testing for Apprentice MES in a GxP-regulated pharmaceutical manufacturing environment for the Sanofi client. I develop and execute SIT and UAT scenarios, configure and validate material data and templates, and document test evidence.

I also develop scenarios for the Apprentice–Athena integration and coordinate with the Athena team to validate expected data and process flows. My work includes risk assessments, requirements traceability, and phase-wise UAT release reports, applying GAMP5 principles and 21 CFR Part 11 and ALCOA+ expectations.

Previously, at Cognizant Technology Solutions, I configured Benchling workflows for the Gilead client and used SQL and Python for data analysis and reporting automation. For the Sanofi client, I configured and migrated legacy templates into Genedata Screener across three assay types.

Experience

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Education

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MC

Mepco Schlenk Engineering College

Bachelor of Technology, Biotechnology

Completed a Bachelor of Technology in Biotechnology in May 2022.

Tech stack

Software and tools used professionally

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