MES Lead

SimoTech • Holly Springs, NC

4d

About The Position

SimoTech is seeking an experienced MES Lead Engineer to lead MES delivery for a major biopharmaceutical project in North Carolina. The role oversees end-to-end Körber/Werum PAS-X implementation, including MES infrastructure, interfaces, system integrations, and GMBR/PMBR development. The engineer coordinates global, site, and cross-functional teams and provides technical leadership throughout the project lifecycle, from requirements and design through configuration, testing, validation, deployment, start-up, and handover.

The position requires hands-on PAS-X experience and the ability to lead technical workshops, design reviews, and stakeholder meetings. The successful candidate will help ensure solutions meet manufacturing and GMP requirements while managing technical decisions, dependencies, issues, and risks.

Requirements

• At least 5 years of experience in a pharmaceutical environment.
• Third-level degree or equivalent in Engineering or a similar discipline.
• Broad technical experience delivering MES systems or projects, including design, configuration, and testing.
• Strong hands-on Körber/Werum PAS-X experience.
• Ability to learn quickly and adapt to new technology.

Nice To Haves

• Experience working in biotech manufacturing operations.

Responsibilities

• Lead end-to-end delivery and implementation of PAS-X MES solutions, ensuring agreed schedules, quality standards, and project milestones are achieved.
• Own and coordinate MES infrastructure, interfaces, and system integrations, working 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; drive technical decisions, manage dependencies, and resolve MES-related issues and risks.
• Provide technical leadership from requirements and design through configuration, testing, validation, deployment, start-up, and handover.

Benefits

• A high degree of autonomy to support the successful candidate in reaching their full potential.
• Long-term project opportunity.
• SimoTech can facilitate the position as a staff engineer.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior