Senior MES Engineer
Summary
Senior MES Engineer (10+ years) who deploys and commissions manufacturing execution systems (Werum PAS-X, Sepasoft, POMS) for life-science clients, leading projects from design through qualification, integrating with systems like DeltaV, SAP, LIMS, PI and Maximo, and leading/mentoring engineers. Up to 25% travel required.
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.