Job Openings
Manufacturing Execution System (MES) Developer
About the job Manufacturing Execution System (MES) Developer
Job Summary
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
- Design, develop, configure, and implement MES solutions for pharmaceutical manufacturing environments.
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Develop and maintain:
- EBR (Electronic Batch Records)
- MBR/GMBR/PMBR
- Recipes and workflows
- Perform recipe authoring and process modeling in MES platforms.
- Integrate MES with SCADA, PLC, ERP, SAP, LIMS, and automation systems.
- Support MES deployment, testing, troubleshooting, and production go-live activities.
- Execute validation activities including IQ/OQ/PQ and ensure compliance with GMP and 21 CFR Part 11.
- Collaborate with cross-functional teams including Manufacturing, QA, Validation, Automation, and IT.
- Support change control, deviation management, and system documentation.
- Participate in Pharma Digital Transformation initiatives and continuous improvement projects.
- Provide technical support and issue resolution during project execution.
Required Skills & Experience
- 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
- Experience in Pharma or Life Sciences industry is mandatory.
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Strong understanding of:
- GMP
- GAMP5
- 21 CFR Part 11
- ISA-95 concepts
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Hands-on experience in:
- Recipe Authoring
- EBR/MBR Design
- Validation Documentation
- Batch Execution
- System Integration
- Experience with SQL, APIs, and automation systems is preferred.
- Excellent communication and stakeholder management skills.
- Ability to work independently in remote/global project environments.
Preferred Qualifications
- Bachelor's degree in Computer Science, Engineering, IT, or related field.
- MES certifications or Pharma automation certifications are a plus.
- Experience working with international pharma clients is preferred.
Nice to Have
- Exposure to Pharma 4.0 initiatives
- Cloud or IIoT integration experience
- Agile project delivery experience
- Knowledge of serialization or manufacturing analytics