- Office in Irvine
The purpose of this position is to conduct maintenance, operation, and repair of facility and production facility equipment complex in nature. This position performs routine maintenance as well as emergency repair of equipment and components.
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.
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
valid CA driver’s license
Skills:
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.
CERTIFICATIONS, LICENSES, REGISTRATIONS: HVAC preferred
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