Qualifications
Support the design and implementation of an MES system for the Drug Product and Finished Goods CDMO facility
Leverage PAS-X design and code prepared from similar FUJIFILM project in Denmark when available
Interface with the IT/OT and I&C teams for coordination and integration of the MES to systems such as SAP and PI
Collaborate with process engineers, product engineers, quality, and production managers to optimize production processes
Leverage Master Batch Records, MES documents, and SOPs from FUJIFILM Denmark and adapt them to support FUJIFILM Holly Springs
Utilize the existing Master Batch Record templates to create new records when applicable
Test MES interfaces to IT systems and equipment, Equipment Statuses, Master Batch Records, and Approval Workflows before going live in the Production environment
Periodic International and Domestic travel may be required Knowledge and Skill
Bachelor's degree in Chemical, Electrical, Computer Science, Biological Science or equivalent
Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals
5+ years' experience designing, configuring, and implementing Automation control systems
2+ years' of direct experience with MES application development and deployment preferred
Preference of having experience with Körber's PAS-X MES software
Experience with working with OEMs to develop integration strategies into ERP and SCADA systems preferred
Excellent oral and written communications skills and fluency in English
Experience in a cGMP facility or working with FDA regulations, or similar regulated industries
Knowledge with Drug Product (DP), and/or Finished Goods Manufacturing (FGM) would be beneficial
Knowledge with Körber PAS-X, SAP (interfaces), OSIsoft PI, and Siemens PLCs is a plus