5+ years' experience designing, configuring, and implementing Manufacturing Execution Systems
3+ years' direct Emerson DeltaV MES experience is required
Experience debugging configuration items within the Emerson DeltaV MES application
Experience in a cGMP facility or working with FDA regulations, S88 batch model, ISA 95, GAMP5 and 21 CFR Part 11 (ERES) is required
Programming skills, preferably within VB Script, XML/XPATH/XSLT and SQL/TSQL is a plus
Excellent oral and written communications skills and fluency in English
Pluses:
Knowledge with Emerson DeltaV, OSIsoft PI, and InfoBatch is a plus, but not required
Day to Day:
Our client is looking for a DeltaV MES (formerly Syncade) Automation Support Engineer to support the system integration and product-specific configuration for two Drug Substance Manufacturing facilities. Process Equipment is controlled primarily by a DeltaV DCS, but product configuration will be completed via DeltaV DCS, DeltaV MES, and a custom FDB-specific system for formula parameters. This role will require coordination with the FDBN DSM MES Team for implementation of DeltaV MES configuration changes and the Manufacturing Team to support a product delivery.
The following scope will be provided by the DeltaV MES Automation Support Engineer:
Support the migration and configuration of an Emerson DeltaV Manufacturing Execution System (MES) to support our vision of paperless manufacturing with full ERP/MES/DCS integration and enforced workflows for a CDMO facility.
Attend regularly scheduled project status meetings with FDBN System SME.
Review product-specific customer requirements and evaluate them against current DeltaV MES capabilities.
Coordinate with various project workstreams including FDBN Automation, FDBD Automation, Process Sciences, Process Engineering, Manufacturing, QA, and others as needed.
Perform simulation of DeltaV MES logic, MES Core Functions, and troubleshoot issues as they arise.
Assist the MES Team in writing and reviewing cGMP system documentation and execution of test protocols.
Assist in supporting our Configuration Management process and ensuring data integrity of our system.
Provide on-call support to Operations activities.
Complete Safety, Project Procedure, and Project Instruction training as required.