Pharma Suite MES Configuration Expert

Job Title : Rockwell FTPS MES Modeler

Location : Mumbai / Pune

Experience Required : 6 to 12 years

Key Responsibilities :

• Recipe Development & Configuration :
• Gathering requirements for PI designing of a product
• Liaising with various product (operations, validation) experts and subject matter experts to determine the requirements
• Design, author, and configure Electronic Batch Records (EBRs) using Rockwell FactoryTalk Pharma Suite (FTPS).
• Gather and analyse requirements for new product recipes by liaising with operations, validation, and subject matter experts.
• Enable review-by-exception through robust recipe / workflow implementation.
• Troubleshoot and defects resolution during validation of PI’s.
• Strong Pharmaceutical, Bio Tech, Manufacturing and Shop Floor Order processes knowledge to convert the site requirements into Batch Records
• MES Implementation & Integration :
• Implement MES solutions and integrate them with ERP systems and control equipment.
• Validate recipes with internal and site teams, ensuring alignment across departments.
• Documentation & Compliance :
• Document MES configurations and validate EBRs.
• Ensure compliance with FDA and GMP guidelines.
• Maintain documentation in line with Life Sciences validation processes.
• Project Coordination & Communication :
• Provide regular status updates to the Project Manager on progress, issues, and risks.
• Work with product vendors on issues during upgrades.
• Facilitate meetings and follow up on action items.
• IT Skills :
• Knowledge on SQL development, VB6, C#, .Net.

Skills & Qualifications :