MES Lead

MES Lead Engineer

SimoTech is seeking an experienced MES Lead Engineer with 6+ years’ experience to lead MES delivery for a major biopharmaceutical project in North Carolina. The role will oversee end-to-end PAS-X implementation, including MES infrastructure, interfaces, and GMBR/PMBR development, while coordinating global, site, and cross-functional teams. Strong hands-on Körber/Werum PAS-X experience and the ability to lead technical workshops and stakeholder meetings are essential.

Requirements

Key Responsibilities

• Lead the end-to-end delivery and implementation of PAS-X MES solutions, ensuring agreed schedule, quality, and project milestones are achieved.
  
• Own and coordinate MES infrastructure, interfaces, and system integrations, working closely with platform, automation, IT/OT, and manufacturing teams.
  
• Lead the design, configuration, testing, and implementation of electronic batch records, including GMBRs and PMBRs.
  
• Collaborate with global and site MES teams, system platform leads, process SMEs, Quality, and Validation to ensure solutions meet manufacturing and GMP requirements.
  
• Lead technical meetings, design reviews, and workshops, driving technical decisions, managing dependencies, and resolving MES-related issues and risks.
  
• Provide technical leadership throughout the project lifecycle, from requirements and design through configuration, testing, validation, deployment, start-up, and handover.
  

Qualifications & Experience

• Minimum of 5 years’ experience in a pharmaceutical environment.
  
• Education to a third level degree or equivalent in Engineering or similar.
  
• Any experience of working in Biotech manufacturing operations is preferred.
  
• Broad technical experience in the delivery of MES systems/projects including design, configuration and testing is essential.
  
• Demonstrated ability to learn quickly and adapt to new technology.
  

Benefits

What SimoTech Can Offer

• Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
  
• Long term project opportunity
  
• SimoTech can facilitate this position as a staff engineer