Newark Metro Area, NJ
The ECQ Planner 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. The incumbent in this role, will be responsible for planning validation and maintenance activities related to both GMP and non GMP laboratory and process equipment. The incumbent will be responsible for receiving, coordinating and planning work related to on-demand work orders and routine scheduled maintenances. The incumbent will also coordinate work with outside vendors and serve as an escort for vendor performed maintenance at times. The incumbent will work heavily in the CMMS, Blue Mountain RAM, and will be responsible for entering data, pulling schedules and reports. The incumbent in this role will have specific job tasks and processes to follow to perform their job. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently, develop potential solutions and courses of action.
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.
Service Contract Support
Assist with the management of Vendor service contracts to support equipment and systems
Provide feedback to departmental leadership on vendor performance and needs.
Departmental Metrics / KPI s
May be asked to pull data and reports from Blue Mountain RAM system to assist in the development of staff metrics.
Maintain and update metrics monthly.
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
Promotes and maintains compliance with corporate, safety, security and regulatory policies
Maintains all assigned Corporate, Facilities, GMP and EHS training as required
Required Competencies-Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
Strong knowledge of facility management systems such as CMMS (Computerized Maintenance Management Systems).
Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Familiarity with FDA / cGXP environments and associated compliance regulations
Adept in Microsoft Office Suite Word, PowerPoint, Excel and Outlook, and the ability to learn new software, such as enterprise business, building management, security, and maintenance management systems.
Proficient at writing well-formulated emails and notifications. Ability to effectively communicate with employees, contractors and vendors. Ability to follow oral and written instructions, read, interpret and update engineering manuals/drawings relevant to the trade or the assigned task
Self-starter who is able to work both independently without direct supervision or in a team environment
Problem Solving / Troubleshooting
Action Oriented / Tenacity
Education & Experience
AA / AS degree or acceptable trade certification from technical
Minimum 3-5 years of facilities maintenance/ operations experience at and industrial or commercial site or related experience and/or equivalent combination of education and experience
GMP facility experience preferred but not required
Physical / Mental Demands:
Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 50lbs
Ability to sit, stand, walk and move within workspace for extended periods
Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling
Primarily office environment
Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
Ability to work safely when working alone or working with others.