Senior Manufacturing Systems Engineer

2 days ago

Bhavnagar, Gujarat, India beBeeManufacturing Full time ₹ 80,00,000 - ₹ 1,20,00,000
Manufacturing Execution System Specialist

We are seeking an experienced Manufacturing Execution System (MES) specialist to support the implementation and maintenance of our MES system. The successful candidate will have a strong understanding of pharma shop floor operations and regulatory requirements, as well as experience with MES platforms or similar systems in GxP-regulated environments.

The ideal candidate will be responsible for ensuring adherence to global regulations, including FDA 21 CFR Part 11 and EU GMP, and will have experience with validation documentation and execution, especially for GxP Category 4 & 5 systems. They will also be skilled in resolving front-end MES issues and supporting end-users post-deployment.

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.

This is a fantastic opportunity for an experienced MES specialist to join our team and contribute to the success of our business.

Required Skills and Qualifications:

To be successful in this role, you will need:

  • Bachelors degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
  • Prior hands-on experience with MES platforms or similar systems in GxP-regulated environments.
  • Proven experience in validation documentation and execution, especially for GxP Category 4 & 5 systems.
  • Strong communication and interpersonal skills, with the ability to work effectively in a team environment.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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