IT Manufacturing Systems Leader

2 weeks ago

Morādābād, Uttar Pradesh, India beBeeExpert Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Job Overview:

We are seeking an experienced professional to lead the implementation of our manufacturing execution system (MES). The ideal candidate will possess a deep understanding of global regulations and have hands-on experience with MES platforms in GxP-regulated environments.

Key Responsibilities:

  • MES Implementation: Representing site-specific needs during MES design, configuration, and deployment.
  • Validation Leadership: Leading IQ, OQ, PQ, UAT, and traceability matrix execution.
  • Documentation Ownership: Managing GxP documentation (URS, FS, DS, test cases, validation plans/reports).
  • MES Product Expertise: Maintaining deep knowledge of MES functionality and architecture.
  • Front-End Support: Acting as the first point of contact for MES application issues and user support.
  • Training & Adoption: Delivering training and ensuring user readiness for MES usage.
  • Data Management: Supporting data collection, migration, and master recipe creation.
  • Audit Readiness: Ensuring all documentation and systems are compliant and audit-ready.

Required Qualifications:

The successful candidate will hold a Bachelors degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field. A Masters degree with specialization in Industrial Automation, Pharmaceutical Technology or related fields is preferred.

Desirable Certifications:

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

Benefits:

This role offers opportunities for professional growth and development in a dynamic and challenging environment.

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