Senior MES Implementation Specialist

7 days ago

Madurai, Tamil Nadu, India beBeeImplementation Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Senior MES Implementation Specialist

We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional expertise in Manufacturing Execution Systems (MES) and Level 2 systems.

The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5).

  • MES Design and Deployment: Represent site-specific needs during MES design, configuration, and deployment.
  • Validation Leadership: Lead IQ, OQ, PQ, UAT, and traceability matrix execution.
  • Documentation Management: Manage Good eXchange Practice (GxP) documentation (User Requirements Specification, Functional Specification, Design Specification, test cases, validation plans/reports).
  • MES Product Expertise: Maintain deep knowledge of MES functionality and architecture.
  • Front-End Support: Act as the first point of contact for MES application issues and user support.
  • Training and Adoption: Deliver training and ensure user readiness for MES usage.
  • Data Management: Support data collection, migration, and master recipe creation.
  • Audit Readiness: Ensure all documentation and systems are compliant and audit-ready.

Required qualifications include:

  • Bachelor's degree: Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
  • Regulatory Compliance: GAMP 5 for system validation in regulated environments.
  • Computer System Validation: CSV for compliance with Good eXchange Practice (GxP).
  • MES Platform Certifications: e.g., Werum PAS-X, Siemens Opcenter, or Rockwell
  • Electronic Records and Signatures: 21 CFR Part 11 Compliance Training

This is an excellent opportunity for professionals who are passionate about technology and manufacturing to take their career to the next level. If you have a strong background in MES and are looking for a challenging role, we encourage you to apply.

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