We are looking for a robust 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
- 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.
📌 MES Validation SME (Rockwell MES) | 5-8 Years of experience | Pharma client exp is mandatory (Bengaluru)
🏢 Cygnus Professionals
📍 Bengaluru
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