MES Validation SME (Rockwell PharmaSuite / MES)
- Location
- Pan India
- Salary
- Not specified
- Company
- Akash pawar
Job description
• Role & Company / Project Overview Cygnus Pro is seeking an experienced QA / Validation Subject Matter Expert with deep expertise in Rockwell PharmaSuite / Rockwell MES and Computer System Validation (CSV) in GxP-regulated manufacturing environments. This is a long-term contract role leading end-to-end validation, recipe configuration, electronic batch record (EBR) execution, and compliance activities across the complete MES lifecycle. • Key Responsibilities & Daily Duties - End-to-End CSV Leadership: Author, review, and execute validation deliverables (Validation Plans, Traceability Matrices, Protocols, Summary Reports) in strict compliance with GxP and GAMP standards. - Rockwell MES Expertise: Lead MES recipe creation, configuration, testing, execution, and validation across key modules: * Recipe Management & Workflow Configuration * Material Management & Production Execution * Electronic Batch Records (EBR) * System Configuration & Enterprise Integrations (ERP, LIMS, Automation) - Full SDLC & Agile Delivery: Drive validation activities across requirements gathering, functional design reviews, UAT, sprint ceremonies, deployment, and hypercare support. - Cross-Functional Collaboration: Partner with global business, functional, technical, and quality stakeholders to maintain continuous validation readiness. • Required Qualifications, Skills & Experience - Core Experience: Strong hands-on background in Computer System Validation (CSV) within regulated pharma / life sciences manufacturing. - Platform Specialization: Deep hands-on experience with Rockwell PharmaSuite / Rockwell MES. - Process Mastery: Proven track record in recipe validation, EBR configuration, and deviation/defect management. - Methodologies: Strong working knowledge of SDLC and Agile delivery models. - Preferred Skills: Experience with ALM / qTest, GxP compliance, and MES integration with ERP / LIMS / PLC / SCADA automation layers. • Working Hours, Shifts & Location Details - Remote (Pan India). - Contract type: Long-term contract. • Compensation & Benefits - Not specified. • Application Instructions - Submit updated resume directly with subject line 'Application - MES Validation SME (Rockwell) - [Your Name]'.