What are the responsibilities and job description for the Automation CapEx Project Manager (Pharmaceuticals) position at Insight Global?
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
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 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
Salary : $84 - $117
