Senior MES Engineer

YK Solutions•Raleigh, NC

2d•Hybrid

About The Position

The Senior MES Engineer designs, configures, integrates, implements, tests, commissions, and qualifies Manufacturing Execution System (MES) solutions for industrial processes and machinery. The role works directly with customers to identify requirements, evaluate MES platforms, develop specifications, and deliver solutions that integrate with level two and level four systems. It is a leadership position that may involve leading engineering teams and is expected to eventually lead an MES office in North Carolina. The engineer acts as a solution architect and technical lead, developing MES strategies that combine process knowledge, equipment design, quality standards, and information technology to reduce downtime, improve regulatory compliance, and increase efficiency. The position also includes project management for projects up to $1 million, with responsibility for execution plans, schedules, budgets, financial reporting, team coordination, and project profitability. The role may serve as project manager on smaller projects and includes business development, including attending trade shows and industry associations. The role is based in Raleigh, North Carolina, with a hybrid work model and up to 25% travel to client sites. The employee must live in North Carolina and will regularly work from the Raleigh office, particularly during the initial period. Over time, work will be divided among the Raleigh office, a home office, and client sites.

Requirements

Must live in North Carolina.
Bachelor of Science degree in Engineering, Computer Science, or Applied Sciences.
More than 8–10 years of overall MES experience, including at least 4 years of Life Science MES experience.
Ability to travel up to 25%.
Ability to act as a solution architect and conceptualize, detail, and implement MES solutions for industrial processes and machinery.
Broad engineering skillset and ability to work independently, lead projects technically, and guide lower-level engineers and technicians.
Familiarity with life-sciences regulatory requirements, including cGMP and 21 CFR Part 11.
Experience coordinating multiple systems spanning controls through ERP, including PLC/DCS, historian technology, reporting systems, relational databases, and ERPs, and creating interfaces between them.
Experience across all phases of Life Science MES projects, including conceptual design, basis of design, implementation, testing, start-up, and commissioning.
System architecture experience with both white-field and brown-field projects.
MES solution deployment experience with platforms including Werum PAS-X, Sepasoft, or POMS.
Aptitude for business development and ability to bring in business, including through trade shows and associations.

Nice To Haves

More than 10 years of experience.
Proficiency in designing and implementing integrated EBR recipes using GAMP5, S88, and S95 standards.
Understanding of manufacturing processes and system configuration, with ability to recommend optimal configurations.
Understanding of warehouse and inventory management in a GMP facility.
Experience supporting software and configuration for external system interfaces such as DeltaV, SAP, LIMS, PI, and Maximo.
Strong knowledge of historian technology and reporting systems.
Experience with relational databases such as SQL and Oracle.
Strong knowledge of IT/OT networking.
Excellent technical writing and verbal communication skills.
Working knowledge of Microsoft Office products.
Experience leading teams of engineers or technicians delivering MES solutions.
Experience mentoring less experienced engineers.
Professional references, preferably one each from a subordinate, peer, and manager.
Experience working for a systems integrator or an integrator background.
Interest in leading an MES office in North Carolina.

Responsibilities

Design, configure, and deliver innovative MES solutions and design standards, independently or as a team leader.
Act as a solution architect to conceptualize, detail, and implement MES solutions that meet customer requirements.
Develop MES strategies integrating process knowledge, equipment design, quality standards, and information technology.
Interact directly with customers to identify requirements, evaluate MES platforms, and develop specifications.
Lead implementation, testing, start-up, commissioning, and qualification of MES solutions.
Lead project execution, including developing execution plans, work breakdown structures, budgets, schedules, task priorities, and time tracking.
Track and report project finances, identify problems early, manage and resolve conflicts, and attend project status meetings.
Oversee daily operations and activities for projects up to $1 million and help ensure overall project profitability.
Act as technical lead on projects and guide lower-level engineers and technicians.
Serve as project manager on smaller projects where needed.
Develop business and secure repeat work with new and existing customers, including attending trade shows and industry associations.
Eventually lead an MES office in North Carolina.