MES Lead

MES Lead Engineer Simo. Tech 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 Simo. Tech Can Offer Role provides a high degree of autonomy to allow the successful candidate to reach their full potential. Long term project opportunity Simo. Tech can facilitate this position as a staff engineer