MES Leadership Role

7 days ago

Anantapur, Andhra Pradesh, India beBeeOperations Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
System Operations Leader

Job Overview:

  • The System Operations Leader will lead MES design, configuration, and deployment to meet site-specific needs.
  • This role is responsible for leading IQ, OQ, PQ, UAT, and traceability matrix execution, ensuring all documentation and systems are compliant and audit-ready.

Key Responsibilities:

  • Develop deep knowledge of MES functionality and architecture, with a focus on GxP-regulated environments.
  • Serve as the first point of contact for MES application issues and user support, providing timely resolutions and training as needed.
  • Collaborate with cross-functional teams to ensure seamless data collection, migration, and master recipe creation, while maintaining system integrity and regulatory compliance.

Requirements:

  • 6-8 years of experience in the pharmaceutical industry, with hands-on experience in MES platforms or similar systems.
  • Bachelor's degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
  • Proven track record in validation documentation and execution, particularly in GxP Category 4 & 5 systems.
  • Experience in resolving front-end MES issues and supporting end-users post-deployment, with a strong understanding of audit processes and documentation expectations.

Preferred Qualifications:

  • Master's degree with specialization in Industrial Automation, Pharmaceutical Technology, or related technical fields.
  • Proficiency in GAMP 5 for system validation in regulated environments, as well as CSV (Computer System Validation) for compliance with GxP.
  • MES Platform Certifications, such as Werum PAS-X, Siemens Opcenter, or Rockwell, along with 21 CFR Part 11 Compliance Training for electronic records and signatures.

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