SUMMARY

The Senior MES Engineer will lead design, configuration, implementation, and commissioning of Manufacturing Execution System (MES) solutions with integration to Level 2 and Level 4 systems. Acting as a solution architect, this role requires conceptualizing, detailing, and deploying MES solutions for industrial processes and machinery in the Life Sciences industry. The position involves leadership of engineering teams, direct customer interaction, and support of business development initiatives.

REQUIRED QUALIFICATIONS

• Bachelors Degree in Engineering, Computer Science, or Applied Sciences
• 10+ years of overall MES experience, including at least 4 years in Life Sciences
• Proven expertise in all phases of MES projects from conceptual design through commissioning
• Hands-on experience deploying MES solutions with Werum PAS-X, Sepasoft, POMS, or similar platforms
• Strong knowledge of cGMP, 21 CFR Part 11, GAMP5, S88, and S95 standards
• Experience leading engineering teams and mentoring less experienced engineers
• Technical proficiency in MES integration with ERP, PLC/DCS, historian systems, relational databases, and reporting systems
• Ability to conceptualize, design, and implement whitefield and brownfield MES solutions independently
• Strong communication, problem-solving, and people skills
• Based in North Carolina (onsite) with willingness to travel 25 percent

• Act as technical lead and solution architect for MES projects, including conceptual design, basis of design, implementation, testing, start-up, commissioning, and qualification
• Lead and mentor lower-level engineers and technicians, guiding teams through MES deployment projects
• Develop MES strategies that integrate process knowledge, equipment design, and quality standards to optimize efficiency and regulatory compliance
• Oversee project execution including schedules, budgets, task prioritization, reporting, and financial tracking for projects up to $1M
• Deploy MES solutions using Werum PAS-X, Sepasoft, POMS, or similar platforms
• Design and implement integrated EBR recipes following GAMP5, S88, and S95 standards
• Coordinate system integration with controls, ERP, historian technologies, relational databases (SQL, Oracle), and reporting systems
• Ensure MES solutions comply with cGMP, 21 CFR Part 11, and Life Sciences regulatory requirements
• Participate in business development, trade shows, and industry associations to secure new work
• Provide oversight and coordination for multiple systems, including PLC/DCS, ERP, and MES interfaces
• Travel up to 25 percent to customer sites and project locations