The Facility Coordinator is responsible for coordinating/planning the USWM Navy Yard building and equipment maintenance activities, including scheduling and planning repairs; organizing, generating and tracking Facilities records in the Blue Mountain Regulatory Asset Management system; spare parts inventory management, and processing Deviations, Change Controls, and CAPAs within the Facilities department. DUTIES AND RESPONSIBILITIES: The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.
- Coordinate & schedule preventive maintenance (PM), corrective maintenance, and calibration activities with vendors and equipment/area owners in a dynamic manufacturing environment, including proactive and regular communication of schedule and status with stakeholders. This may include rescheduling on short notice to minimize impact to GMP manufacturing and testing laboratory operations and follow-up with vendors regarding any outstanding work orders
- Act as CMMS (computerized maintenance management system) Facilities business owner, including creating/processing CMMS work instructions, maintenance and calibration templates, asset records and associated documentation. Ensure timely creating, completion and approval of CMMS records according to the governing SOPs and Work Instructions
- Ensure Facilities documents and records are completed in a timely manner, and in accordance with GMP practices. Organize and clearly document maintenance records, including filing original documents.
- Assist with the tracking, processing and renewal of maintenance service agreements prior to expiration dates. Update service agreement tracker, maintain service agreement files, and forward approved POs to the vendor.
- Assist with development, processing and submission of Quality System documentation, including SOPs, Deviations, CAPAs and Change Controls
- Perform all activities in compliance with applicable cGMP guidelines
QUALIFICATIONS:
- BS/BA or equivalent post-secondary education in a technical or scientific field
- 3+ years' experience or familiarity with GMP clean room equipment maintenance and calibration practices and terminology
- Experience authoring and/or processing Deviations, CAPAs and Change Controls in a GMP environment, including use of root-cause analysis or other investigation techniques
- Experience with Computerized Maintenance Management Systems - ideally Blue Mountain Regulatory Asset Management system preferred
- Proficient in use of standard office software such as MS Word, MS Excel, MS PowerPoint, etc.
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. PHYSICAL DEMANDS:
- Frequently required to stand
- Frequently required to walk.
- Frequently required to sit.
- Frequently required to talk or hear.
- Occasionally required to lift light weights (less than 25 pounds)
- Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus
WORK ENVIRONMENT:
- The noise level in the work environment usually is quiet.
Equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability, age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.
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