Job Description
Day to Day:
Our client is looking for a Syncade MES Engineer to join their team. 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 Syncade MES Automation Support Engineer:
• Support the design and implementation of an Emerson Syncade Manufacturing Execution System 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 DSM MES Team.
• Provide design review and input on system requirements and lifecycle documentation related to the following MES functions:
o Order Management, Material Management
o Bill of X (Materials, Parameters, Transactions)
o Workflow Execution
o Electronic Batch Record (EBR)
o Quality Review Manager (QRM)
o Weigh & Dispense
• Coordinate with various project workstreams including Automation, CSV, CQV, Utilities, Process Engineering, QA, and others as needed.
• Responsible for translation of system requirements into test protocols
• Responsible for testing of MES project, which includes infrastructure setup, software installation, recipe development, and User Acceptance Testing (UAT) with users.
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Required Skills & Experience
Must Haves:
• 2+ years’ experience designing, configuring, and implementing Manufacturing Execution Systems
• 2+ years of direct Emerson Syncade experience
• Experience debugging configuration items within the Syncade / 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)
Nice to Have Skills & Experience
Plus:
• Direct Emerson DeltaV MES experience plus
• Knowledge with Emerson DeltaV, OSIsoft PI, and InfoBatch is a plus, but not required
• Programming skills, preferably within VB Script, XML/XPATH/XSLT and SQL/TSQL is a plus
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.