Job Description

Must Haves:

• 5+ years’ direct experience working with Emerson DeltaV DCS
• Experience in a cGMP pharmaceutical facility working with FDA regulations is required
• Working knowledge of Kneat validation software is required
• Excellent organizational, oral, and written communication skills and fluency in English with the ability to effectively communicate within cross-functional teams and to management

Pluses:

• Knowledge with Drug Substance Manufacturing (DSM) would be beneficial
• MasterControl, ComplianceWire, TrackWise, and Veeva experience is a plus

Day to Day:

Our client in Raleigh-Durham is seeing a downstream process automation DeltaV support Engineer to join their team. This individual will support the system integration management for downstream equipment and systems in the areas of Buffer Preparation/Hold, Purification – Chromatography (LPC), Viral Filtration (VF), Ultrafiltration (UF), Diafiltration (DF), and Dispensing contained within the Drug Substance Manufacturing (DSM) area of the facility. Equipment is controlled primarily by a DeltaV DCS. The System integrator will update DeltaV configuration from code received from the corporate headquarters to align with site-specific equipment requirements. This role will require coordination with and management of the System Integrator.

The following scope will be provided by the Downstream Process Automation DeltaV Support Engineer:

• Attend regularly scheduled project status meetings with Automation engineers and the System Integrator
• Attend weekly DSM Automation Huddle meeting to provide status to the DSM Automation Team
• Provide design review and input on Automation requirements for one or multiple process areas
• Attend and provide feedback during System Integrator functional reviews of certain process areas
• Review life cycle documentation
• Review and approve Kneat documents including: DeltaV software FATs, SATs, Automation Commissioning Test Protocols, software OQs, and Software Installation Verification protocols.
• Support generation of Kneat documents.
• Manage/oversee the System Integrator’s support of loop checks & commissioning activities for certain process areas
• Coordinate with various project workstreams including Automation, CSV, CQV, Utilities, Process Engineering, and others as needed

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