Manufacturing Execution System Site Specialist

2 weeks ago

Belgaum, Karnataka, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Title: MES Site SME

Job Description:

The role of a Manufacturing Execution System (MES) Site Subject Matter Expert (SME) is crucial in ensuring the smooth operation of production processes and maintaining regulatory compliance. The successful candidate will possess a deep understanding of MES functionality, configuration, and compliance requirements.

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.

Experience:

  • 6 to 8 years of experience in pharmaceutical manufacturing with strong understanding of pharma shop floor operations and regulatory requirements.
  • 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.
  • Application support experience in resolving front-end MES issues and supporting end-users post-deployment.
Skill Requirements:

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.

Additional Skills:

  • Knowledge of data analytics tools, Edge Cloud deployment experience with IoT and IIoT, L2 integration with MES, MES integration with SAP.

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