MES Validation Subject Matter Expert - Rockwell PharmaSuite

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. - 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.