Senior MES Engineer

Location: Raleigh, NC | Work Mode: On site | Experience: Mid-senior

About the role

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

• Deliver innovative MES solutions and design standards either self-directedly or as a leader of a team.
• Act as a solution architect to conceptualize, detail, and implement MES solutions for industrial processes and machinery that meet customer requirements.
• Develop an MES strategy that integrates process knowledge, equipment design, and quality standards with information technology to reduce downtime, elevate regulatory compliance, and introduce efficiency gains.
• Perform project management responsibilities including:
  • Developing project execution plans, work breakdown structures, and associated budgets.
  • Task prioritization, scheduling, ordering, time tracking, and reporting.
  • Financial tracking and reporting.
  • Early problem identification and conflict management/resolution.
  • Leading and supporting a team, attending project status meetings.
  • Overseeing daily operations and activities of projects up to $1M.
  • Ensuring overall profitability of the project.
• Act as technical lead on projects and guide lower-level engineers and technicians.
• Act as Project Manager on smaller projects.

Requirements

Education: A Bachelor of Science degree in Engineering, Computer Science, or the Applied Sciences is required.

• Greater than 10 years of experience with capabilities in the following areas is preferred:
  • MES solution deployment experience with 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.
  • Understanding of manufacturing processes and system configuration to 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

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

Working Environment

• Standard office environment, on-site office environment, diverse industrial environments.
• Frequent use of a personal computer, facsimile/copy machines, and phones.

About Wunderlich-Malec

As a 100% Employee-Owned Company, our people are passionate about solving unique engineering challenges. With the support of industry experts, they successfully execute projects of any size while meeting requirements of scope, schedule, and budget.

Wunderlich-Malec has been providing customers with engineering, system integration, and fabrication solutions for more than 40 years. With offices throughout the US and over 500 professionals on staff, we are one of the largest and most well-established engineering companies in the United States. We have successfully finished numerous projects for US clients worldwide.

Wunderlich-Malec ranks on Inc. 5000’s Fastest-Growing Private Companies list and is a GSA Schedule holder with the Federal Government for professional engineering services and manufacturing.