Role Overview:We are looking for an experienced MES Validation SME with strong expertise in Rockwell PharmaSuite / Rockwell MES and Computer System Validation (CSV) within regulated environments. The role involves MES recipe configuration, production workflow validation, electronic batch record validation, and end-to-end testing to ensure compliance and reliable system operations.Responsibilities :- Configure, create, execute, and validate MES recipes using Rockwell PharmaSuite / Rockwell MES.- Manage and validate recipe management, workflow configuration, material management, production execution, and Electronic Batch Records (EBR).- Perform system configuration, integration testing, and validation activities in compliance with applicable regulatory requirements.- Support the end-to-end Software Development Lifecycle (SDLC), including requirements gathering, functional and design reviews, development support, testing, validation, and User Acceptance Testing (UAT).- Prepare and review validation documentation, test cases, test scripts, and execution evidence.- Support system deployment, release activities, and post-deployment hypercare.- Collaborate with business users,



technical teams, and stakeholders to resolve issues and ensure successful MES implementation.- Participate in Agile ceremonies, sprint planning, and release planning.- Ensure adherence to Computer System Validation (CSV) practices and GxP compliance requirements.Requirements :- 8 - 13 years of relevant experience in MES implementation, validation, or related pharmaceutical manufacturing systems.- Solid hands-on experience with Rockwell PharmaSuite / Rockwell MES.- Proven experience in Computer System Validation (CSV) within regulated environments.- Extensive knowledge of MES recipe creation, configuration, execution, and validation.- Strong understanding of recipe management, workflows, material management, production execution, and EBR.- Experience across the SDLC, including requirements gathering, design reviews, testing, UAT, deployment, and hypercare.- Experience working in Agile delivery environments.- Excellent stakeholder communication, documentation, and problem-solving skills. (ref:hirist.tech)

📌 MES Validation Subject Matter Expert - Rockwell PharmaSuite (Chennai)
🏢 RANDOMTREES PRIVATE
📍 Chennai