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.
• 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.
• 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.
• Strong understanding of:
  • GMP
  • GAMP5
  • 21 CFR Part 11
  • ISA-95 concepts
• 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