Project Planner - GMP Facilities
Edison-New Brunswick Metro Area, NJ
Strong knowledge of facility management systems such as CMMS (Computerized Maintenance Management Systems).
Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. A
Familiarity with FDA / cGXP environments and associated compliance regulations
- Supports the successful operation of the GMP facility, laboratory and business functions at multi use sites through interaction with internal customers and external service providers.
- Responsible for planning validation and maintenance activities related to both GMP and non GMP laboratory and process equipment.
- Responsible for coordinating and planning work related to on-demand work orders and routine scheduled maintenances.
Work with equipment operations team to plan and schedule routine equipment calibrations, preventative maintenance and requalification activities.
Serve as the first point of contact for any on demand work orders generated by the laboratory community.
Field any on demand work requests. Assess priority and assign and respond as needed.
Work with equipment operations team to schedule and prioritize all on demand equipment work orders.
Interface with OEM (Original Equipment Manufacturer) to schedule routine and on demand work requests, to request spare parts and expedite services as required.
Confirm that incoming vendors are appropriately trained for work that is being performed.
Escort vendors on site as needed to facilitate completion of work.
Future state work with delivery team to schedule purchase, install, commissioning and qualification of new equipment and facilities.
Inventory Management in CMMS System
Enter, create and modify data in the site CMMS system, Blue Mountain RAM.
Preventative Maintenance Work Plans
Manages new, revised or deactivation of preventative maintenance work plans associated with assets within CMMS
Generate PM work orders within the CMMS and issues to the responsible departments
Coordinates PM work orders with the affected departments or outside vendors if necessary
Closure of preventative work orders
Demand Maintenance Management
Manage demand maintenance requests from customers and internal staff within CMMS
Communicate with our customers to provide updates and clarifications if necessary
Generate demand work orders within the CMMS and issues to the responsible groups
Coordinates demand work orders with the affected departments or outside vendors if necessary