Senior MES Implementation Specialist

20 hours ago

Nellore, Andhra Pradesh, India beBeeMes Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Title: Senior MES Implementation Specialist

This is a critical role that requires strong technical skills and a proven track record of successfully implementing Manufacturing Execution Systems (MES) in regulated environments. The successful candidate will be responsible for leading the implementation of MES across multiple sites, ensuring compliance with global regulations such as FDA 21 CFR Part 11 and EU GMP.

The ideal candidate will have at least 6 years of experience in the pharmaceutical industry, with a strong understanding of pharma shop floor operations and regulatory requirements. They will also have prior hands-on experience with MES platforms or similar systems in GxP-regulated environments. In addition to technical expertise, the candidate should possess strong communication and interpersonal skills, with the ability to work effectively with cross-functional teams.

Key Responsibilities:
- Represent site-specific needs during MES design, configuration, and deployment
- Lead IQ, OQ, PQ, UAT, and traceability matrix execution
- Manage GxP documentation (URS, FS, DS, test cases, validation plans/reports)
- Maintain deep knowledge of MES functionality and architecture
- Act as the first point of contact for MES application issues and user support

Required Skills and Qualifications:
  • MES system configuration, deployment, and validation
  • Front-end application troubleshooting and user support
  • GxP and 21 CFR Part 11 compliance
  • Validation protocol development and execution (IQ, OQ, PQ, UAT)
  • Documentation management (URS, FS, DS, traceability matrices)
  • Data migration and master recipe creation

Desirable Skills:
  • Knowledge of data analytics tools
  • Edge Cloud deployment experience with IoT and IIoT
  • L2 integration with MES
  • MES integration with SAP
  • Understanding of network and databases

Benefits:
The successful candidate will have the opportunity to work on a high-profile project, gaining valuable experience and skills in the field of MES implementation. They will also be part of a dynamic team, working closely with colleagues to achieve common goals.

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