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Strategy & Consulting - Global Network - Industry X - Digital Manufacturing MES Engineer

Mexico City Job No. r00283799 Full-time - Hybrid

Descripción De La Posición

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The MES Functional Specialist plays a critical role in implementing and supporting Manufacturing Execution Systems (MES) for clients in regulated industries such as pharmaceuticals and biotech. This role bridges business requirements and technical solutions, ensuring compliance with GMP and other regulatory standards while optimizing manufacturing processes.

Key Responsibilities

Requirements Gathering & Analysis

  • Collaborate with business stakeholders to capture functional requirements for MES solutions.

  • Conduct AS-IS and TO-BE process analysis for manufacturing workflows.

System Design & Configuration

  • Design and configure MES functionalities, including:

    • Electronic Batch Records (EBRs)

    • Recipe authoring and management

    • Equipment and material management

  • Develop functional specifications and ensure alignment with business needs.

Integration & Validation

  • Support integration between MES and ERP systems (e.g., SAP) and automation layers (e.g., DeltaV).

  • Prepare and execute validation protocols (IQ/OQ/PQ) in compliance with GAMP5 and FDA regulations.

Testing & Deployment

  • Perform functional testing, troubleshoot issues, and ensure successful deployment.

  • Support hypercare and post-go-live activities.

Documentation & Compliance

  • Maintain comprehensive documentation, including URS, FRS, and SOPs.

  • Ensure adherence to GMP, 21 CFR Part 11, and data integrity standards.

Training & Support

  • Provide end-user training and knowledge transfer.

  • Act as a subject matter expert for MES processes and best practices.

Requisitos

Qualifications:

  • Bachelor’s degree in Engineering, Computer Science, Information Technology, or related field.

  • Advanced english level.

  • 3–5 years of hands-on experience with MES systems (e.g., Syncade, PharmaSuite, PAS-X)

  • Strong understanding of manufacturing processes and regulatory requirements (GMP, FDA).

  • Familiarity with ERP integration (SAP preferred) and automation systems.

  • Knowledge of IT lifecycle management and validation processes.

  • Soft Skills: Strong analytical and problem-solving abilities. Excellent communication and stakeholder management skills. Ability to work in a global, cross-functional team environment.

Nice-to-Have

  • Certifications in GAMP5, ITIL, or Project Management.

  • Exposure to cloud-based MES solutions and digital manufacturing initiatives.

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