Technical SME for Manufacturing Execution Systems

8 hours ago

Kannur, Kerala, India beBeeTechnical Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Job Title: Technical SME for Manufacturing Execution Systems

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  • ">A highly skilled and experienced professional with strong knowledge of manufacturing execution systems (MES) is required to support the implementation and validation of MES at our pharmaceutical manufacturing sites.">
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Job Summary:

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We are seeking a seasoned expert in MES to join our team. The ideal candidate will have 6-8 years of experience in the pharmaceutical industry, including technical and functional experience in MES & L2 systems.

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The successful candidate will be responsible for supporting the successful implementation of the Manufacturing Execution System (MES) & L2 at the Halol & Baska pharmaceutical manufacturing sites. This includes ensuring that site-specific manufacturing processes are accurately captured and reflected in the global MES solution.

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The role requires strong communication and interpersonal skills, as well as the ability to work under pressure and manage multiple priorities.

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Key Responsibilities:

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• Representing site-specific needs during MES design, configuration, and deployment

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• Leading IQ, OQ, PQ, UAT, and traceability matrix execution

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• Managing GxP documentation (URS, FS, DS, test cases, validation plans/reports)

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• Maintaining deep knowledge of MES functionality and architecture

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• Acting as the first point of contact for MES application issues and user support

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• Delivering training and ensuring user readiness for MES usage

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• Supporting data collection, migration, and master recipe creation

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• Ensuring all documentation and systems are compliant and audit-ready

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Requirements:

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• Bachelor's degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field

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• Preferred: Master's degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Industrial Automation, Pharmaceutical Technology or related technical fields

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• Strong understanding of pharma shop floor operations and regulatory requirements

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• Prior hands-on experience with MES platforms or similar systems in GxP-regulated environments

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• Proven experience in validation documentation and execution, especially for GxP Category 4 & 5 systems

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• Experience in resolving front-end MES issues and supporting end-users post-deployment

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• Familiarity with audit processes and documentation expectations

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Desirable Skills:

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• Knowledge of data analytics tools

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• Edge Cloud deployment experience with IoT and IIoT

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• L2 integration with MES

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• MES integration with SAP

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• Understanding of network and databases

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Working Environment:

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The role will require working at the Halol & Baska pharmaceutical manufacturing sites. Travel to other locations may also be necessary.

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What We Offer:

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A competitive compensation package and excellent opportunities for career growth and development.

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How to Apply:

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For further information, please submit your application through our website.

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