# Manasha Karunanidhi

Manasha Karunanidhi is a remote worker on Himalayas, Validation SME at Capgemini, based in India.

Source: https://himalayas.app/@manashakarunanidhi

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

| Detail | Value |
| --- | --- |
| Availability | Looking for a job |
| Location | India |
| Authorized to work in | India |
| 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, SIT, UAT, Functional Testing, Risk Based Validation, 21 CFR Part 11, ALCOA+ Standards, Data Integrity, Requirement Traceability, Evidence Analysis, Audit Trails |

## About

```text
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

### Validation SME (current)

[Capgemini](https://himalayas.app/companies/capgemini-technology-services). Mar 2026 - Present

```text
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.
```

Skills: Apprentice-MES, Athena-Integration, GxP, GAMP-5-Best-Practices, 21-CFR-Part-11, ALCOA+-Standards, Jira, Xray-Test-Management, SIT, UAT, Risk-Assessment, Traceability

### Product Configurator

[Cognizant Technology Solutions](https://himalayas.app/companies/cognizant). Jan 2024 - Mar 2026

```text
Configured Benchling across Registry, ELN, Inventory, templates, and sample-management workflows for life-sciences users. Performed functional testing, UAT, regression testing, and configuration verification.
```

Skills: Benchling, ELN, Inventory, Templates, sample-management, Veeva-Vault, SQL, Python, UAT, Regression-Testing

### Product Analyst

[Cognizant Technology Solutions](https://himalayas.app/companies/cognizant). Jul 2022 - Dec 2023

```text
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.
```

Skills: Genedata-Screener, Assay-Configuration, Template-Migration, Dose-Response-Analysis, IC50-Determination, EC50, DC50, Client-Collaboration

## Education

### Mepco Schlenk Engineering College

Bachelor of Technology, Biotechnology

```text
Completed a Bachelor of Technology in Biotechnology in May 2022.
```

## Tech stack

- Terraform
- Jira
- Python
- Confluence
- SQL
- AWS

To contact Manasha, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire).

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