MES Validation Subject Matter Expert - Rockwell PharmaSuite
First seen by Alion on Oct 23, 2026.
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.
Skills
MES Support, MES Implementation, CSV, System Validation, System Configuration, Workflows, Manufacturing Applications, Manufacturing Execution System