"Alerted.org

This position requires taking ownership of assignments directed at improving total operating efficiency, minimizing equipment downtime and improving internal administrative processes. This position also requires documentation support to ensure that documents such as validations, EIN’s and PM’s are correct and up to date for the assigned equipment and processes.

POSITION REQUIREMENTS

+ · _Performing routine preventative maintenance on facilities Air Conditioning equipment and central plant equipment._

+ · _Conduct Facilities Work Requests for internal customers._

+ · _Investigation, corrections and documentation of internal alarms from the “Process Alarm Monitoring System”._

+ · _Ordering and maintaining spare parts inventory and repair parts associated with facilities work requests._

+ · _Daily tours and verification of operation making necessary adjustments of all facilities equipment located on rooftop, in the central plant, and throughout the facility._

+ · _Documentation, meetings, organization, clean up._

+ · _Respond to all system alarm communications._

+ · _Carries out duties in compliance with established business policies._

+ · _Carry out various tasks with site security systems such as conducting security badging; maintain security access control (C-Cure 9000), and CCTV systems._

+ · _On-call responder for alarm calls, 24/7 coverage._

+ · _Carries out duties in compliance with established business policies._

+ · _Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies._

+ · _Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities._

+ · _Serve as system administrator, maintain, troubleshoot, and program site trending and monitoring systems._

+ · _Conduct maintenance and repair of facility process equipment and systems, including but not limited to water purification systems, heating and cooling systems, humidity control equipment, and building control systems._

+ · _Support coordination and timely execution of work requests, and support facility technicians with the completion of daily tasks._

+ · _Support cross-functional training of the technical staff._

+ · _Coordinate site escort of contractors and vendors. Ensure vendors are properly trained prior to executing work._

+ · _Generate reports, data and format graphed data in support of Quality system requirements, as well as internal and regulatory audits._

+ · _Ensure compliance with all Facilities and Quality System procedures. Remain knowledgeable of current federal and international regulations, including FDA 21CFR part 820, FDA 21CFR part 11, and ISO 13485. Maintain working knowledge of local and state building codes as applicable to work performed on campus._

+ · _Exhibit professionalism with both internal and external business associates._

+ · _Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Perform other duties & projects as assigned._

Education and Experience

+ _High school diploma or equivalent_

+ _8 to 10 years maintenance experience preferably in Biotech, cGMP, medical or health related environment or equivalent_

+ _Must be available to work any shift and be “on call” via pager and/or cell phone_

+ _Clean & valid CA driver’s license_

Skills – General & Technical

+ _Experience with power tools and their associated safety procedures_

+ _Experience conducting routine building/grounds maintenance_

+ _Experience working with and troubleshooting equipment electrical systems_

+ _Experience with machine shop equipment, power tools and their associated safety procedures_

+ _Experience conducting routine maintenance and repairs on automation equipment_

+ _Experience working in a high paced manufacturing environment_

+ _Ability to work within a self-directed work team environment preferred_

+ _Experience working in combination with Engineering on projects preferred_

+ _HVAC equipment knowledge preferred_

+ _Refrigeration systems knowledge preferred_

+ _Ability to prioritize multiple tasks and work independently._

+ _Basic computer skills including, file management, MS Word, Excel and Access preferred_

+ _Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR preferred_

+ _Excellent understanding and application of safety procedures_

+ _Excellent use of communication, cooperation and interpersonal skills_

+ _Excellent documentation skills preferred._

+ _Ability to prioritize multiple tasks and work independently._

+ _Basic skills with machine drill press, small hand tools, welding preferred._

+ _Basic electro-mechanical skills_

+ _Basic computer skills including file management, MS Word, and preventative maintenance software preferred._