Systems Manager Pharmaceutical Manufacturing

2 days ago

Pune, Maharashtra, India beBeeManufacturing Full time ₹ 1,80,00,000 - ₹ 2,50,00,000
Pharmaceutical Manufacturing Systems Manager

We are seeking a highly skilled and experienced Pharmaceutical Manufacturing Systems Manager to lead the successful implementation of our Manufacturing Execution System (MES) and L2 systems at our manufacturing sites.

This is a key role responsible for supporting the successful implementation of the MES & L2 at our pharmaceutical manufacturing sites. The site-specific manufacturing processes will be accurately captured and reflected in the global MES solution.

  • Representing site-specific needs during MES design, configuration, and deployment
  • Leading IQ, OQ, PQ, UAT, and traceability matrix execution
  • 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

Key Requirements:

  • Bachelor's degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field
  • Preferred: Master's degree with specialization in Industrial Automation, Pharmaceutical Technology, or related technical fields
  • Specific Certification: GAMP 5, CSV (Computer System Validation), MES Platform Certifications, 21 CFR Part 11 Compliance Training
  • Experience: 6 to 8 years in the pharmaceutical industry with strong understanding of pharma shop floor operations and regulatory requirements

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