Senior MES Engineer

KLM Careers; Raleigh (NC); On-site; USD 100,000 - 130,000; Full time

Job summary

A technology solutions provider is looking for a Senior MES Engineer in Raleigh, North Carolina. The successful candidate will lead projects in the life science sector, delivering innovative MES solutions, overseeing technical teams, and managing project execution. Candidates should have over 10 years of engineering experience, preferably in system implementation and regulatory compliance. This position requires strong problem-solving skills and a capability for team leadership. Knowledge of MES tools and life science regulations is essential.

Qualifications

• 10+ years of experience in MES projects.
• Proficient in designing integrated EBR recipes.
• Experience with life science industry regulatory compliance.

Responsibilities

• Deliver innovative MES solutions and design standards.
• Oversee project management responsibilities up to $1M.
• Lead engineering team and mentor less experienced engineers.

Skills

Technical proficiency in software design

Problem-solving ability

People skills

Project management

Technical writing skills

Communication skills

Team leadership

Knowledge of regulatory requirements

Warehouse and inventory management

Understanding of IT/OT networking

Education

Bachelor of Science degree in Engineering, Computer Science or Applied Sciences

Tools

Werum PAS-X

Sepasoft

POMS

SQL

Oracle

MS Office products

DeltaV

SAP

LIMS

PI

Maximo

Job description

Must be a US Citizen or Green Card holder.

• This position requires demonstrated technical proficiency in software design and configuration of MES solutions with integration capabilities to level two and four systems.
• The Senior MES Engineer will interact directly with the customer and lead a team of Wunderlich‑Malec engineers in identifying requirements, evaluating MES platforms, developing specifications, and implementing/testing/commissioning/qualifying MES solutions.
• This position is a leadership role within the business unit and requires strong problem‑solving ability, well‑balanced people skills, an aptitude for business efficiency, and an interest in creating partnerships.
• The Senior MES Engineer demonstrates success by securing repeat work with both new and existing customers.

RESPONSIBILITIES

• This position requires the ability to deliver innovative MES solutions and design standards either self‑directedly or as a leader of a team. The candidate will act as a solution architect and must have the ability to conceptualize, detail, and implement MES solutions for industrial processes and machinery that meet our customers requirements. This involves the development of an MES strategy that integrates process knowledge, equipment design, and quality standards with information technology to reduce downtime, elevate the level of regulatory compliance, and introduce efficiency gains through the effective use of available technologies.
• This position oftentimes requires the following project management responsibilities: developing project execution plans, work breakdown structures, and associated budgets, task prioritization and scheduling, task ordering, time tracking and reporting, financial tracking and reporting, early problem identification, conflict management/resolution, leading and supporting a team, and attending project status meetings. Also includes overseeing daily operations and activities of a project(s) up to $1M. This position is often responsible for ensuring the overall profitability of the project.
• The ideal candidate must have a diverse engineering skillset with the ability to work independently. Will act as technical lead on projects and guide lower‑level engineers and technicians. Could also act as Project Manager on smaller projects.

QUALIFICATIONS

• Education: A Bachelor of Science degree in Engineering, Computer Science or the Applied Sciences required.
• Experience: Greater than 10 years with capabilities in the below areas is preferred:
• MES solution deployment experience with but not limited to Werum PAS‑X, Sepasoft, or POMS.
• Proven experience with all phases of MES projects including conceptual, basis of design, implementation, testing, start‑up, and commissioning in the Life Science industry.
• Familiarity with relevant regulatory requirements of the life science industry such as cGMP, 21 CFR Part 11, etc.
• Demonstrated proficiency with designing and implementing integrated EBR recipes using GAMP5, S88, and S95 standards.
• Understand the manufacturing processes and system configuration and make informed recommendations regarding optimal system configuration.
• Understanding of warehouse and inventory management specifically in a GMP facility.
• Support software and configuration required for external systems interfaces such as DeltaV, SAP, LIMS, PI, and Maximo.
• Strong knowledge of historian technology and reporting systems.
• Experience with relational databases such as SQL, Oracle, etc.
• Strong knowledge of IT/OT networking.
• Excellent technical writing and verbal communication skills.
• Working knowledge of MS Office products.
• Experience leading a team of engineers/technicians to provide MES solutions.
• Experience mentoring less experienced engineers.
• Professional references, preferably one from each of the following: a subordinate, a peer, and a manager.
• Ability to travel up to 25%.

PHYSICAL DEMANDS OF POSITION

• Seeing, color perception, hearing, clear speech, dexterity in hands, driving, lifting, ability to mount/dismount equipment, pushing and pulling.