Senior Technician, Equipment

Job Title: Senior Technician, Equipment
Role Level: Individual Contributor
Supervisor/Manager

Title:

Manager, Facilities and Environmental Health and Safety
Job Location & Environment: Irvine, CA / Corporate Office / Controlled Cleanroom / R&D / Warehouse


Job Description

Summary:

The Senior Technician, Equipment owns the Preventive Maintenance (PM), calibration, and equipment qualification programs for manufacturing, quality, and R&D equipment. Including scheduling and performing the work directly and coordinating with outside vendors to keep equipment qualified, calibrated, and audit-ready under Jena Valve’s medical device quality management system.

• Owns the scheduling and on-time completion of all Preventive Maintenance (PMs) and calibrations activities for manufacturing and R&D equipment, fixtures, and tools.
• Performs equipment PM, calibration, and qualification/verification activities directly.
• Schedules and coordinates with outside service vendors for PM, calibration, and repair work requiring outside certification or specialized expertise; oversees vendor work on-site and reviews vendor certificates and reports for accuracy before closeout.
• Performs unscheduled maintenance and troubleshooting of equipment, fixtures, and tools, including generating and managing work orders through completion.
• Receives and responds to automated electronic (text/email) equipment notifications and alarms after hours and on weekends.
• Populates, updates, and maintains the equipment maintenance software, partnering with Quality to keep records accurate and current.
• Completes new equipment intake, qualification, and inactivation documentation and supports equipment receipt and inspection by verifying new equipment is as ordered and undamaged and keeping it quarantined and labeled until qualified for use.
• Supports First Article Inspections and equipment qualification activities in partnership with Manufacturing Engineering and Quality.
• Maintains and troubleshoots specialized equipment supporting production, including the Millipore RO/DI water system, chemical fume hoods, compressed dry air (CDA) system, and cleanroom environmental controls (HVAC, HEPA filtration, and differential pressure monitoring).
• Assembles equipment, fixtures, and tools as needed.
• Uses inspection and measurement equipment, including gauges, scales, and visual digital inspection systems (Micro-Vu), to support calibration and verification activities.
• Supports the processes and controls for inventory and raw material supplies as they relate to Facilities equipment and tooling.
• Adheres to all aspects of the Jena Valve Quality Management System in the performance of their duties.

• High school diploma minimum;
  Associate degree in a technical discipline desired.
• Minimum of 4 years’ experience performing equipment preventive maintenance and calibration in a highly regulated industry (Medical, Aerospace, Automotive).
• Demonstrated experience scheduling and managing outside service vendors/contractors for equipment maintenance, calibration, or repair work.
• Familiarity with procedures, equipment, and tools used in the medical device industry or other regulated industries.
• Experience working within an electronic equipment or calibration software system preferred.

• Must be able to work effectively and collaborate within cross-functional teams and with outside vendors.
• Strong organizational and scheduling skills; able to manage multiple PM and calibration timelines and vendor commitments without missing due dates.
• Ability to follow written and verbal instructions.
• Ability to take initiative and complete hands-on work independently.
• Ability to focus on tasks that…