MES Validation SME (Rockwell MES)

RandomTrees LLC; Hyderabad, Chennai District, Bengaluru; Híbrido; INR 900 000 - 1 700 000; Tempo integral

Resumo da oferta

RandomTrees LLC in Hyderabad seeks an experienced professional with strong Computer System Validation (CSV) in regulated environments and hands-on expertise with Rockwell PharmaSuite / Rockwell MES. You will contribute to MES recipe creation, configuration, execution, and validation, including EBRs and system integration.

The role covers SDLC activities from requirements gathering, design reviews, development support, testing/validation, UAT, deployment, and post-go-live hypercare.

Qualificações

• Strong CSV experience in regulated environments.
• Hands-on Rockwell PharmaSuite / Rockwell MES experience.
• Proven MES recipes creation, configuration, execution and validation.
• In-depth Rockwell MES components: Recipe Management, Workflow Configuration, Material Management, Production Execution, EBR, System Configuration & Integration, Testing and Validation.

Conhecimentos

CSV in regulated

PharmaSuite

Rockwell MES

MES recipes

Workflow config

Material mgmt

Production execution

EBR

System integration

Testing/Validation

SDLC

Agile delivery

Sprint ceremonies

UAT

Documentation

Ferramentas

ALM

qTest

Descrição da oferta de emprego

Mandatory Skills & Experience

Strong experience in Computer System Validation (CSV) within regulated environments.

Extensive hands-on experience with Rockwell PharmaSuite / Rockwell MES.

Proven track record in MES recipe creation, configuration, execution, and validation.

Well-versed in all major aspects of Rockwell MES, including:

• Recipe Management
• Workflow Configuration
• Material Management
• Production Execution
• Electronic Batch Records (EBR)
• System Configuration and Integration
• Testing and Validation Activities

Strong understanding of the Software Development Lifecycle (SDLC) from:

• Requirements Gathering
• Functional & Design Reviews
• Development Support
• Testing & Validation
• User Acceptance Testing (UAT)
• Deployment and Hypercare Support

Experience working in Agile delivery models, participating in sprint ceremonies and release planning.

Excellent stakeholder communication and documentation skills.

Preferred Skills

• Experience with ALM, qTest, or similar test management tools.
• Knowledge of GxP-regulated environments and compliance requirements.