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
REQUIRED SKILLS AND EXPERIENCE
Must Haves: • 5+ years' direct experience working with Emerson DeltaV DCS • Experience supporting downstream equipment and systems in the areas of buffer prep, purification, chromatography, viral filtration, ultrafiltration, diafiltration • 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