We are looking for an experienced QA/Validation SME with deep expertise in Computer System Validation (CSV) and Rockwell MES to support regulated manufacturing environments.
Key Responsibilities
- CSV & Compliance: Drive end-to-end CSV activities, author validation deliverables, and ensure adherence to GxP and quality standards.
- Rockwell MES Lifecycle: Own MES recipe creation, configuration, workflow setup, Electronic Batch Record (EBR), and validation.
- SDLC & Agile Delivery: Participate in sprint ceremonies, requirement reviews, UAT, and end-to-end testing across the delivery lifecycle.
- Cross-Functional Collaboration: Partner with global business, functional, and technical stakeholders with minimal supervision.
Qualifications & Skills
- Core Experience: Strong background in CSV within regulated environments and hands-on expertise in Rockwell PharmaSuite / Rockwell MES.
- SDLC Expertise: Experienced in requirements gathering, design reviews, testing, deployment, and hypercare support.
- Preferred: Familiarity with ALM, qTest, and MES integrations with ERP, LIMS, or automation systems.
📌 Rockwell MES - Pharma Consultant (India)
🏢 Cygnus Professionals
📍 India
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