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