MES Validation SME (Rockwell MES)

Mandatory Skills & Experience

Strong experience in Computer System Validation (CSV) within regulated environments.

Extensive hands-on experience with Rockwell PharmaSuite / Rockwell MES.

Proven track record in MES recipe creation, configuration, execution, and validation.

Well-versed in all major aspects of Rockwell MES, including:

Recipe Management

Workflow Configuration

Material Management

Production Execution

Electronic Batch Records (EBR)

System Configuration and Integration

Testing and Validation Activities

Strong understanding of the Software Development Lifecycle (SDLC) from:

Requirements Gathering

Functional & Design Reviews

Development Support

Testing & Validation

User Acceptance Testing (UAT)

Deployment and Hypercare Support

Experience working in Agile delivery models, participating in sprint ceremonies and release planning.

Excellent stakeholder communication and documentation skills.

Preferred Skills

Experience with ALM, qTest, or similar test management tools.

Knowledge of GxP-regulated environments and compliance requirements.

Exposure to MES integrations with ERP, LIMS, or automation systems.