Job Description

Must Haves:

• 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.

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