This position is a 12 month contract opportunity which is expected to be on-site in Clayton, NC.
Overview
The scope of this position is a pharmaceutical Project Manager to join our Greenfield Operations team. Specifically for overall greenfield site wide readiness activities (ie. document control, metrology, preventative maintenance, environmental monitoring, spare parts and similar activities) to bring our new facility online.
The best candidates will be responsible for exploring, mapping, and identifying program gaps between work packages. The next step will be to use the knowledge gained to establish a remediation plan, ownership and find a suitable anchor point. A primary responsibility will be coordinating between work package areas and the execution schedule through delivery and into operation. Additionally, the candidate will be responsible for alignment between the designated work packages and cross-functional teams, ensuring that no items are missed or neglected.
Cross functional focus includes:
* IT Systems
* Facilities
* Clean utilities
* Warehouse
* Construction
* GxP operations during construction
The ideal candidate will have extensive experience in:
* Greenfield Start-up operations preferably with Finished production (Assembly/Packaging)
* Pharmaceutical Project management, Implementations, process improvements
* Broad-based project management skills with solid fundamentals (schedule, risk, budget, resources)
Position Requirements
* Identify, develop and manage interface agreements between the central team, local site, work packages vendors and functional areas to include milestones and schedules in high level of detail.
* Ability to create detailed project plans and business cases suitable for presentation to leadership
* Coordination of program level and local stakeholders for coordination and discovery efforts to close program gaps
* Provide periodic project status updates & identify current risk assessments, mitigation of risks, etc. * Extensive collaboration within Novo Nordisk network to gain best practices and specifications that will transfer to local site.
* Responsible for adherence to mechanisms for monitoring project progress, intervention & problem solving with line managers or personnel.
* Discover and evaluate to ensure installation, troubleshooting, qualification & validation of buildings & equipment meets all commitments defined in the project.
* Follow all safety & environmental requirements in the performance of duties.
* Lead / manage the execution of capital projects according to company policies & procedures.
* Work with outside design firms as needed to bring projects (equipment &/or building) from conceptual design phase to execution
* Maintain effective communication & ensure alignment in coordination with multiple project teams.
* Manage major milestones, schedules & monthly cost plans through Clarity PEM process.
* Responsible for stakeholder management & communications to management, project team & other involved units.
* Assist with any training required of personnel supporting the project.
* Responsible for managing project change control process to ensure project remains within defined scope, budget & schedule.
* Tracking project performance, metrics & KPI's.
Required Skillsets
* Bachelor's degree in engineering or related technical field or equivalent combination of experience & education required.
* Advanced Project Management competencies obtained through relevant PM training or experience preferred.
* Minimum five (5) years of engineering experience in facility infrastructure as well as manufacturing experience in a pharmaceutical environment preferred.
* Minimum five (5) years of proven project / portfolio management skills with major capital projects.
* Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC, & electrical systems preferred.
* Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts preferred.
* Working knowledge/experience of building & utility equipment preferred.
* Demonstrates functional/business understanding preferred.
* Demonstrates superior written & oral communication skills preferred.
* Extensive knowledge of project management preferred.
* Develops & maintains strong internal relationships preferred.
* Proficiency at problem solving, negotiation, conflict management, & interpersonal skills preferred.
* Demonstrates leadership skills; can act as project lead & lead cross functional project teams in the development & implementation of projects preferred.
* Has the ability to influence others on objectives & projects outcomes preferred.
* Basic understanding of contractual documents & ability to create work plans & detailed project schedules preferred.
* Proven project management experience with direct management of multiple projects simultaneously preferred.
* Proven expertise in mentoring/development, planning/organizing, managing execution, & revising the work plan for complex problems solved by cross functional teams preferred.
* Initiative, ability to function independently preferred.
* Good judgment in decision making as well as very good leadership skills preferred.
* Must Function well in team environment.
