Qualification Project Manager job in Morris Plains
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
The Qualification Project Manage leads the overall execution of Commissioning and Qualification projects regarding initiation, budgeting, scheduling, monitoring, and closure according to GMP, Novartis, Regulatory and safety requirements.|
•Takes a leadership role in managing multiple Commissioning and Qualification projects
•Manages the Commissioning and Qualification project portfolio and engineering project dashboard
•Mentors junior qualification engineers on the team and provides guidance.
•Supervises work of contractors and junior engineers in the execution of projects.
•Defines goals, scope and timeline of the project.
•Ensures necessary communication within the project engineering team (meetings, minutes, action items) and coordinates interfaces with other departments
•Coordinates with engineering team and quality organizations, according to SOPs and is-sues documentation according to site and global engineering compliance requirements
•Writes, reviews or revises Standard Operating Procedures related to Engineering Com-missioning and Qualification systems and Processes
•Writes and executes Change Controls in support of project execution
•Nominates the project team together with the project champion/customer and involved line management
•Leads the Commissioning and Qualification project teams. Delegate's responsibility to project team members.
•Coordinate internal resources and third parties/vendors for the flawless execution of Commissioning and Qualification projects.
•Manages project risks and strategic influencing to maintain project timelines.
•Ensures compliance with Novartis and Regulatory regulations for Commissioning and Qualification
•Verifies project delivers required URS requirements.
•Create and maintain comprehensive project documentation.
•Ensures readiness for inspections together with quality organizations
•Ensures the project turnover documentation to the user organization.Education:
BS in Engineering, Pharmaceutical Technology, or equivalent scientific degree or equivalent experience
Experience / Skills:
7+ years experience executing Commissioning and Qualification projects of various size and scope. 5+ years Project Management experience in a GMP regulated environment (pharmaceutical preferable). Experience with manufacturing and laboratory equipment and change controls. Experience writing SOP's, user requirements, and qualification project documentation