Job Description

Must Haves:

• 5+ years of project management experience
• 4+ years of Direct experience working with Emerson DeltaV DCS
• Experience working alongside of a system integrator reviewing design, automation in place, overseeing project timelines, and working directly with Capex equipment teams
• Experience in a cGMP pharmaceutical facility working with FDA regulations is required
• Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels

Pluses:

• Experience with DeltaV MES
• Knowledge of Drug Substance Manufacturing (DSM) process
• ComplianceWire, TrackWise, and Veeva experience is a plu
• Greenfield project experience

Day to Day:

Our client is seeking 2 Automation Project Managers to join their team in Raleigh-Durham NC. This individual will be brought on to help manage the system integration for new production introduction to a Drug Substance Manufacturing (DSM) building. Equipment is controlled primarily by a DeltaV DCS, but updates to DeltaV MES and other integrated systems may require management. This role will support equipment start-up and management of system integrator resources to complete commissioning, qualification, and initial engineering runs of DeltaV software.

The following scope will be provided by the Automation Project Management Engineer:

• Coordinate project execution with engineering design firm, CAPEX team, & Automation process area owners, and system integrator.
• Manages delivery of specification documents (e.g., platform requirements specification (PRS), functional specification (FS), design qualification (DQ), etc.) and test protocols (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
• Initiate design and provide input on Automation requirements for one or multiple process areas
• Manage/oversee the System Integrator’s support of loop checks & commissioning activities
• Provide on-call support to Commissioning, Qualification, Validation, and Operations activities.
• Coordinate with various project workstreams including Automation, CSV, CQV, Utilities, Process Engineering, Manufacturing, and others as needed
• Complete Safety, Project Procedure, and Project Instruction training as required

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