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.