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
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