Our client is looking for a Syncade developer to join their team in Raleigh-Durham. This individual will 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 specific system for formula parameters. This role will require coordination with the 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.
- Attend regularly scheduled project status meetings with System SME.
- Review product-specific customer requirements and evaluate them against current DeltaV MES capabilities.
- 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.
Must Haves :
4+ years’ experience designing, configuring, and implementing Manufacturing Execution SystemsExperience debugging configuration items within the Syncade / Emerson DeltaV MES applicationExperience in a cGMP facility or working with FDA regulations, S88 batch model, ISA 95, GAMP5 and 21 CFR Part 11 (ERES) is requiredPlusses :
Direct Emerson DeltaV MES experience plusKnowledge with Emerson DeltaV, OSIsoft PI, and InfoBatch is a plus, but not requiredProgramming skills, preferably within VB Script, XML / XPATH / XSLT and SQL / TSQL is a plus