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Job Title: Facilities Maintenance Specialist (CMMS Coordination)
Department: Facilities Maintenance
Summary: Responsible for the administration, coordination and completion of tasks on BMRAM to maintain the required cGMP state of the Computerised maintenance management system for the Facility through strict adherence to Standard Operating Procedures (SOPs) and cGMP's.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Administration and Coordinaton activities for Blue Mountain Regulatory Asset Manager (BMRAM), the on- site Computerized Maintenance Management (CMMS) System.
* Coordinate the creation of equipment, system/subsystem, and location hierarchies in BMRAM.
* Create assets (Equipment Code Numbers – ECNs), schedules and work events for all systems and equipment. Prepares and maintains Maintenance Plan/Schedule records.
* Assist users of BMRAM to navigate through the database system or troubleshoot problems encountered.
* Raising change controls, creating and updating new and effective documentation to support BMRAM operations via workflows on qualified documentation systems.
* Provision of project support to technical groups that require BMRAM input.
* Maintain the integrity of information within the CMMS system.
* Supporting change controls and Executing test plans for changes to BMRAM qualified systems.
* Completing Corrective and Preventative Actions (CAPA) associated with BMRAM and asset management in a timely manner.
* Provide guidance and support to colleagues relating to initiation and closure of Change control, workflows, CAPAs etc.
* Identifying and implementing changes and improvements to BMRAM operation and maintenance activities on BMRAM .
* Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
* Follows current good manufacturing practices (cGMPs) and good business practices.
Education and Experience:
* BS/BA in Engineering, Life Sciences or related field preferred; will substitute relevant work experience in lieu of degree requirement. Minimum of 3-5 years experience in an SOP, ISO, or similar regulated environment strongly desired
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