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.

Key Responsibilities

• Lead or support the delivery of MES projects with a primary focus on Werum PAS-X.
  
• Translate process and manufacturing requirements into:
  • MES functional specifications
    
  • Master batch records
    
  • Electronic workflows
    
  • Materials and equipment models
    
  • Exception handling logic
    
• Configure and support PAS-X modules including:
  • 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:
  • Scope definition
    
  • Schedule tracking
    
  • Vendor coordination
    
  • Risk management
    
  • Change control
    
  • Stakeholder reporting
    
• Support system integration with:
  • 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 hypercare and steady-state operations.
  
• Drive continuous improvement initiatives to improve batch release time right-first-time performance and data integrity.
  

Required Qualifications

• Bachelors 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.
  
• Proven expertise in:
  • Electronic Batch Records
    
  • Recipe / workflow design
    
  • GMP manufacturing processes
    
  • Master data modeling
    
  • Exception management
    
• Experience managing project timelines deliverables and cross-functional stakeholders.
  
• Strong knowledge of:
  • GAMP 5
    
  • 21 CFR Part 11
    
  • Annex 11
    
  • Data integrity principles
    
• Excellent documentation communication and problem-solving skills.
  

Preferred Experience

• 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.
  
• Previous capital project or digital transformation program experience.
  

Key Competencies

• MES project delivery
  
• Werum PAS-X expertise
  
• EBR optimization
  
• Stakeholder management
  
• GMP compliance mindset
  
• Cross-functional collaboration
  
• Risk and issue management
  
• Continuous improvement