Senior MES Manager

3 days ago

Surat, Gujarat, India beBeeSystem Full time ₹ 18,00,000 - ₹ 24,00,000

Job Summary

We seek an experienced professional with 6-8 years in the pharmaceutical industry to lead MES & L2 system management.

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

Key Responsibilities:

  • 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.

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 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.

Experience:

  • 6-8 years of experience in the pharmaceutical industry.
  • 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.

Essential Skills:

  • 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.

Behavioral Skills:

  • Strong communication and interpersonal skills.
  • Proactive problem-solving and risk management.
  • High attention to detail and compliance mindset.
  • Ability to work under pressure and manage multiple priorities.
  • Detail-oriented with a focus on compliance and quality.
  • Proactive problem-solving and decision-making.

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