Job Description

We are looking for an experienced Manufacturing Execution System (MES) Developer with 6+ years of experience in Pharma Manufacturing and Digital Transformation projects. The ideal candidate should have hands-on expertise in MES implementation, recipe authoring, electronic batch records, system integration, validation, and deployment within regulated pharmaceutical environments.

Experience with platforms such as Werum PAS-X, FactoryTalk PharmaSuite, Emerson Syncade, or Siemens Opcenter will be highly preferred.

Key Responsibilities

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  Design, develop, configure, and implement MES solutions for pharmaceutical manufacturing environments.
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  Develop and maintain:
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    EBR (Electronic Batch Records)
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    MBR/GMBR/PMBR
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    Recipes and workflows
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  Perform recipe authoring and process modeling in MES platforms.
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  Integrate MES with SCADA, PLC, ERP, SAP, LIMS, and automation systems.
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  Support MES deployment, testing, troubleshooting, and production go-live activities.
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  Execute validation activities including IQ/OQ/PQ and ensure compliance with GMP and 21 CFR Part 11.
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  Collaborate with cross-functional teams including Manufacturing, QA, Validation, Automation, and IT.
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  Support change control, deviation management, and system documentation.
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  Participate in Pharma Digital Transformation initiatives and continuous improvement projects.
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  Provide technical support and issue resolution during project execution.

Required Skills & Experience

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  6+ years of experience in MES development/implementation.
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  Strong experience with one or more MES platforms:
  • 
    Werum PAS-X
  • 
    Rockwell PharmaSuite
  • 
    Emerson Syncade
  • 
    Siemens Opcenter
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  Experience in Pharma or Life Sciences industry is mandatory.
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  Strong understanding of:
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    GMP
  • 
    GAMP5
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    21 CFR Part 11
  • 
    ISA-95 concepts
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  Hands-on experience in:
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    Recipe Authoring
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    EBR/MBR Design
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    Validation Documentation
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    Batch Execution
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    System Integration
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  Experience with SQL, APIs, and automation systems is preferred.
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  Excellent communication and stakeholder management skills.
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  Ability to work independently in remote/global project environments.

Preferred Qualifications

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  Bachelor's degree in Computer Science, Engineering, IT, or related field.
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  MES certifications or Pharma automation certifications are a plus.
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  Experience working with international pharma clients is preferred.

Nice to Have

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  Exposure to Pharma 4.0 initiatives
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  Cloud or IIoT integration experience
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  Agile project delivery experience
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  Knowledge of serialization or manufacturing analytics