Executive Technical Lead

24 hours ago

Tiruppur, Tamil Nadu, India beBeeManufacturing Full time ₹ 40,00,000 - ₹ 50,00,000
Job Overview

We are seeking a seasoned professional with extensive experience in the pharmaceutical industry, including technical and functional knowledge of MES & L2 systems. The successful candidate will be responsible for supporting the implementation of Manufacturing Execution System (MES) & L2 at multiple pharmaceutical manufacturing sites.


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.

Requirements
  • Bachelor's degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
  • Preferred: Master's degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Industrial Automation, Pharmaceutical Technology or related technical fields
  • Specific Certification :
    • 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
  • Experience :
    • 6 to 8 years of experience
    • 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

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

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