Upstream Process Automation DeltaV Engineer

Job Title: Upstream Process Automation DeltaV Engineer Location: Raleigh-Durham, NC Experience: 7-12 years Work Type: 12+ months contract

Job Overview: We are seeking an experienced Upstream Process Automation DeltaV Engineer to support system integration and automation within a cGMP pharmaceutical facility. This role will focus on upstream equipment and systems in the Drug Substance Manufacturing (DSM) area, including buffer preparation/hold, purification (chromatography), viral filtration, ultrafiltration, diafiltration, and dispensing. The ideal candidate will manage DeltaV DCS configuration updates, coordinate with system integrators, and ensure compliance with FDA regulations.

Must-Have Qualifications:

7-12 years of experience with Emerson DeltaV DCS

Experience in a cGMP pharmaceutical facility with FDA regulations

Working knowledge of Kneat validation software

Excellent organizational, oral, and written communication skills; fluent in English

Ability to work on-site approximately 75% of the time

Preferred Qualifications (Pluses)

• Experience with upstream equipment such as centrifuges, filtration, and harvest

• Knowledge of Drug Substance Manufacturing (DSM) processes

• Familiarity with MasterControl, ComplianceWire, TrackWise, and Veeva

• Key Responsibilities:

• Support system integration management for upstream equipment and systems

• Attend project status meetings and weekly DSM Automation Huddles to provide updates

• Provide design review and input on automation requirements for one or more process areas

• Review and provide feedback during system integrator functional reviews

• Review and approve Kneat documents including FATs, SATs, Automation Commissioning Test Protocols, software OQs, and Software Installation Verification protocols

• Support generation of Kneat documents

• Manage and oversee system integrator support of loop checks and commissioning activities

• Coordinate with multiple project workstreams including Automation, CSV, CQV, Utilities, and Process Engineering