Manufacturing Systems Expert

3 days ago

Bengaluru, Karnataka, India beBeeSystem Full time ₹ 18,00,000 - ₹ 21,50,000

**Job Summary:**

We seek a seasoned professional with 6-8 years of pharmaceutical industry experience, including technical and functional expertise in MES & L2 systems.

The Site SME MES Project is a key functional and technical expert responsible for supporting the successful implementation of Manufacturing Execution System (MES) & L2 at manufacturing sites.

This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution.

The SME is accountable for leading site-level validation activities and technical owner responsibility, managing GxP documentation related to the MES & L2 system.

The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5).

**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 and Qualifications:**

  • 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 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.

**Required Skills and Competencies:**

  • 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.

**Additional 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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