FACILITIES PLANNER / DOCUMENT SPECIALIST IN PHARMACEUTICAL SUMMIT, NJ 100 % Onsite Position with some flexibility to work Remote.
The GMP Facilities Planner/ Document Specialist supports the successful operation of the GMP facility, and business functions at multi use sites through interaction with internal customers and external service providers.
The incumbent will also coordinate work with outside vendors performing maintenance or calibration activities.
The incumbent will work heavily in the CMMS, Blue Mountain RAM, and Celdox, 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 can recognize problems of moderate scope and complexity, and independently, develop potential solutions and courses of action.
Document Writing (Primary):
Work with Facility Management team to improve documents and route them in the CelDox system.
Assist with the Periodic review of SOP's pertaining to the GMP Facilities and ECQ departments.
Scheduling Responsibilities (Secondary):
Work with Facility Management team to assign internally shared HVAC, Calibration and Electrical trades according to demand and priority.
Confirm that incoming vendors are appropriately trained for work that is being performed.
Future state Work with Facility Management team to assign parts and tools required for maintenance activities and re-stock accordingly.
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.
Provide reports to support validation requirements, deviations .
Preventative Maintenance Work Plans:
Coordinates PM work orders with Facility Management the affected departments or outside vendors if necessary .
Upload of supporting maintenance or calibration documentation to CMMS
Promotes and maintains compliance with corporate, safety, security, and regulatory policies .
Maintains all assigned Corporate, Facilities, GMP and EHS training as required .
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 .
Strong knowledge of facility management systems such as CMMS (Computerized Maintenance Management Systems).
Strong Knowledge of Document Management .
General understanding building systems including life safety, lighting, electrical, HVAC and plumbing .
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 .
Technical Knowledge, Problem Solving / Troubleshooting, Team Player, Multi-tasking, Customer Focus, Document Writing.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Krysty: krysty@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00807
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE