Role Overview

We are looking for a strong and experienced QA/Validation professional with proven expertise in Computer System Validation (CSV) and Rockwell MES. The ideal candidate should possess extensive hands-on experience across the complete MES lifecycle, including recipe creation, configuration, testing, validation, deployment, and production support.
This role requires an individual who can work independently with minimal supervision and effectively collaborate with business, functional, technical, and validation stakeholders in a regulated manufacturing environment.

Mandatory Skills & Experience
• Solid 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.
• Exposure to MES integrations with ERP, LIMS, or automation systems.

Key Expectations
• Drive and support end-to-end CSV activities.
• Author and review validation deliverables and test artifacts.
• Lead MES recipe validation efforts and provide SME guidance.
• Work closely with global teams to deliver high-qual

📌 MES Validation SME (India)
🏢 Cygnus Professionals
📍 India