Senior MES Engineer

Senior MES Engineer needs 10+ years experience

Senior MES Engineer requires:

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%

Senior MES Engineer duties:

• 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.