Must Haves :
- 7-12 years of experience working with Emerson DeltaV DCS
- Experience in a cGMP pharmaceutical facility working with FDA regulations
- Working knowledge of Kneat validation softwar
- Excellent organizational, oral, and written communication skills and fluency in English with the ability to effectively communicate within cross-functional teams and to management
- Ability to work on site 75%
Pluses :
Upstream equipment experience - centrifuges, filtration, harvest, etc.Knowledge with Drug Substance Manufacturing (DSM)MasterControl, ComplianceWire, TrackWise, and VeevaDay to Day :
Our client in Raleigh-Durham is seeing an Upstream Process Automation DeltaV Engineer to join their team. This individual will support the system integration management for upstream 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 DeltaV Engineer :
Attend regularly scheduled project status meetings with Automation engineers and the System IntegratorAttend weekly DSM Automation Huddle meeting to provide status to the DSM Automation TeamProvide design review and input on Automation requirements for one or multiple process areasAttend and provide feedback during System Integrator functional reviews of certain process areasReview life cycle documentationReview 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 Integrators support of loop checks & commissioning activities for certain process areasCoordinate with various project workstreams including Automation, CSV, CQV, Utilities, Process Engineering, and others as needed