Senior MES Engineer Raleigh, NC

Senior MES Engineer Raleigh, NC

JOB DESCRIPTION : 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 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.

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.

QUALIFICATIONS :

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

• 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%

Wunderlich-Malec is an equal opportunities employer and welcomes applications from diverse candidates.

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