Upstream Automation Engineer

Day to Day:
A client of ours in the Raleigh-Durham area is seeking an Upstream DeltaV Engineer to support their facility. This individual will be supporting support the system integration management for upstream equipment and systems in the areas of the Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest contained within the Drug Substance Manufacturing area of the facility. Equipment is controlled primarily by a DeltaV DCS. The System integrator will update DeltaV configuration from code received from another site to align with this site-specific equipment requirements. This role will require coordination with and management of the System Integrator.

The following scope will be provided by the Upstream 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 Integrators support of loop checks & commissioning activities for certain process areas
Coordinate with various project workstreams including, CSV, CQV, Utilities, Process Engineering, and others as needed

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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

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.