Role Overview We are looking for an experienced MES Validation SME with robust 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.
• Strong 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 (Chennai)
🏢 RandomTrees
📍 Chennai