Mes Systems Specialist

9 hours ago

Thāne, Maharashtra, India beBeePharmaceutical Full time ₹ 1,80,00,000 - ₹ 2,40,00,000

Job Overview

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We are seeking an experienced professional to fill the role of MES Systems Manager. The ideal candidate will have a strong understanding of pharmaceutical manufacturing operations and regulatory requirements, as well as hands-on experience with Manufacturing Execution System (MES) platforms.

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The successful candidate will be responsible for ensuring all documentation and systems are compliant and audit-ready. This includes managing GxP documentation, leading IQ, OQ, PQ, UAT, and traceability matrix execution, and maintaining deep knowledge of MES functionality and architecture.

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Key Responsibilities:

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  • Representing site-specific needs during MES design, configuration, and deployment.\
  • Leading IQ, OQ, PQ, UAT, and traceability matrix execution for validation leadership.\
  • Managing GxP documentation (URS, FS, DS, test cases, validation plans/reports).\
  • Maintaining deep knowledge of MES functionality and architecture.\
  • Acting as the first point of contact for MES application issues and user support.\
  • Delivering training and ensuring user readiness for MES usage.\
  • Supporting data collection, migration, and master recipe creation.\
  • Ensuring all documentation and systems are compliant and audit-ready.\
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Requirements

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  • Bachelors degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.\
  • Preferred: Masters degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Industrial Automation, Pharmaceutical Technology or related technical fields \
  • GAMP 5 for system validation in regulated environments.\
  • CSV (Computer System Validation) for compliance with GxP.\
  • MES Platform Certifications e.g., Werum PAS-X, Siemens Opcenter, or Rockwell \
  • 21 CFR Part 11 Compliance Training for electronic records and signatures \
  • 6 to 8 years of experience\
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Desired Skills

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  • Pharmaceutical Manufacturing: Strong understanding of pharma shop floor operations and regulatory requirements.\
  • MES or Digital Systems: Prior hands-on experience with MES platforms or similar systems in GxP-regulated environments.\
  • Validation Expertise: Proven experience in validation documentation and execution, especially for GxP Category 4 & 5 systems.\
  • Application Support: Experience in resolving front-end MES issues and supporting end-users post-deployment.\
  • Audit Experience: Familiarity with audit processes and documentation expectations \

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