Project Engineer (MES)

We are seeking a highly capable Project Engineer with a strong MES focus, specializing in Werum PAS-X, to support the delivery of digital manufacturing and operational excellence initiatives for a pharmaceutical client. This role will play a key part in the implementation, enhancement, and lifecycle management of Manufacturing Execution Systems (MES) across GMP-regulated production environments.

The successful candidate will bring proven experience in PAS-X design, recipe modeling, electronic batch record (EBR) deployment, system integration, and project execution, working closely with manufacturing, automation, validation, IT, and quality teams.

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• Lead or support the delivery of MES projects with a primary focus on Werum PAS-X.
  
• Translate process and manufacturing requirements into:
  
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  • MES functional specifications
    
  • Master batch records
    
  • Electronic workflows
    
  • Materials and equipment models
    
  • Exception handling logic
    
  
  
• Configure and support PAS-X modules including:
  
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  • Electronic Batch Recording (EBR)
    
  • MBR design
    
  • Weigh & Dispense
    
  • Materials Management
    
  • Review by Exception
    
  
  
• Collaborate with process SMEs, operations, QA, and IT to optimize digital batch execution.
  
• Manage project activities including:
  
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  • Scope definition
    
  • Schedule tracking
    
  • Vendor coordination
    
  • Risk management
    
  • Change control
    
  • Stakeholder reporting
    
  
  
• Support system integration with:
  
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  • DeltaV / DCS
    
  • PLCs
    
  • LIMS
    
  • ERP / SAP
    
  • Historians
    
  • Serialization systems
    
  
  
• Coordinate FAT, SAT, UAT, and go-live readiness activities.
  
• Support CSV, IQ/OQ, and validation documentation in line with GAMP 5.
  
• Troubleshoot MES issues during deployment, hyper‑care, and steady‑state operations.
  
• Drive continuous improvement initiatives to improve batch release time, right‑first‑time performance, and data integrity.
  

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• Bachelor’s degree in Engineering, Computer Science, Biotechnology, Pharmaceutical Technology, or related discipline.
  
• 5+ years of project engineering or MES delivery experience within pharmaceutical, biotech, or life sciences manufacturing.
  
• Strong hands‑on experience with Werum PAS‑X / Körber PAS‑X.
  
• Electronic Batch Records
  
• Recipe / workflow design
  
• GMP manufacturing processes
  
• Exception management
  
• Experience managing project timelines, deliverables, and cross‑functional stakeholders.
  
• Strong knowledge of:
  
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  • GAMP 5
    
  • 21 CFR Part 11
    
  • Annex 11
    
  • Data integrity principles
    
  
  
• Excellent documentation, communication, and problem‑solving skills.
  

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• Experience in biologics, sterile fill‑finish, vaccine, or API manufacturing.
  
• Exposure to PAS‑X rollouts, site expansions, or global template deployments.
  
• Familiarity with DeltaV, Syncade, SAP, PI Historian, LIMS, and SCADA integrations.
  
• Experience with recipe standardization and multi‑site MES harmonization.
  
• Knowledge of ISA‑88 / ISA‑95 concepts. xcfaprz
  
• Previous capital project or digital transformation program experience.