MES Project Expert

7 days ago

Anand, Gujarat, India beBeeManufacturing Full time ₹ 21,60,000 - ₹ 28,80,000
Job Title: MES Project Expert

We are seeking an experienced professional with expertise in Manufacturing Execution Systems (MES) to lead the implementation and validation of our site-specific MES solution.

The ideal candidate will have a strong understanding of pharmaceutical industry operations, technical knowledge of MES platforms, and experience in leading cross-functional teams to ensure successful project execution.

A key focus of this role is to maintain deep knowledge of MES functionality and architecture, ensuring seamless integration with SAP and other systems. The SME must also possess excellent communication skills to support training and user adoption across various stakeholders.

Key Responsibilities:
  • MES Implementation and Validation: Representing site-level needs during MES design, configuration, deployment, and validation activities.
  • Technical Leadership: Leading IQ, OQ, PQ, UAT, and traceability matrix execution to ensure compliance with GxP regulations.
  • Documentation Ownership: Managing GxP documentation related to MES, including User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), test cases, and validation plans/reports.
  • SME Support: Acting as the primary point of contact for MES application issues and providing user support to ensure smooth system operation.

Preferred qualifications include a Master's degree in Industrial Automation or Pharmaceutical Technology, with specialization in Computer Science, Production, or Engineering fields.

Specific certifications required include 21 CFR Part 11 Compliance Training for electronic records and signatures, and knowledge of Werum PAS-X, Siemens Opcenter, or Rockwell MES platforms.

The ideal candidate will have hands-on experience with MES platforms, a strong understanding of pharmaceutical shop floor operations and regulatory requirements, and proven experience in validation documentation and execution.

Requirements:
  • Bachelor's degree in Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
  • Experience with data analytics tools, edge cloud deployment, L2 integration with MES, and MES integration with SAP are highly desirable.

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