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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
Message

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

Work history, roles, and key accomplishments

CA
Current

Validation SME

Mar 2026 - Present (8 months)

Support validation and functional testing for ApprenticeMES in a GxP-regulated pharmaceutical manufacturing environment. Develop SIT and UAT test cases, configure material data, and prepare requirements traceability matrices.

Apprentice MES
Athena Integration
GxP
GAMP 5 Best Practices
21 CFR Part 11
ALCOA+ Standards
Jira
Xray Test Management
SITUATRisk AssessmentTraceability
Cognizant Technology Solutions logoCS

Product Analyst

Jul 2022 - Dec 2023 (1 year 5 months)

Configured and migrated legacy base templates into Genedata Screener, recreating approximately 20 templates across 3 assay types. Worked with inhibition, activation, and degradation assays and assay-analysis workflows.

Genedata Screener
Assay Configuration
Template Migration
Dose Response Analysis
IC50 Determination
EC50
DC50
Client Collaboration

Education

Degrees, certifications, and relevant coursework

Mepco Schlenk Engineering College logoMC

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

Availability

Looking for a job

Location

India

Authorized to work in

Salary expectations

2162k+ INR

Job categories

MES Specialist
CSV Specialist
Computer System Validation Specialist
MES Consultant
Digital Manufacturing Validation Specialist
Life Sciences IT Validation Specialist

Skills

MES Validation
Computerized System Validation
GxP
GAMP 5 Best Practices
Pharmaceutical Manufacturing Systems
SITUATFunctional Testing
Risk Based Validation
21 CFR Part 11
ALCOA+ Standards
Data IntegrityRequirement TraceabilityEvidence AnalysisAudit Trails

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