Upstream Automation Engineer

Job Title : Upstream Automation 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