Sr. Automation Capex Project Manager

Day to Day:
Our client is seeing an Automation Project Manager 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 Integrators 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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Must Haves:
Personal ownership and proactive collaboration with external business partners and internal stakeholders
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
Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
Ability to manage commitments while displaying an eagerness to learn and continuously improve
Knowledge of Drug Substance Manufacturing (DSM) process

Pluses:
- experience with DeltaV MES
- 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.