Senior Technician, Equipment

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

JenaValve Technology, Inc. in Irvine, CA, seeks a Senior Technician, Equipment to own PM, calibration, and equipment qualification for manufacturing, QA, and R&D assets, coordinating with vendors to keep systems audit-ready under GMP.

You will schedule work, perform maintenance and calibration, update records, and support incoming equipment qualification and First Article activities in a controlled cleanroom environment.

Qualifications

• High school diploma required; associate degree in a technical discipline preferred.
• 4+ years of PM and calibration in regulated industries.
• Experience managing external vendors for maintenance, calibration, or repair.
• Familiarity with procedures, equipment, and tools used in medical device or regulated environments.
• Experience with calibration software is a plus.

Responsibilities

• Owns scheduling and on-time completion of Preventive Maintenance (PMs) and calibrations for manufacturing and R&D equipment.
• Performs PM, calibration, and qualification/verification activities directly.
• Coordinates with outside vendors for PM, calibration, or repair work; reviews vendor certificates/reports before closeout.
• Performs unscheduled maintenance and troubleshooting; manages work orders to completion.

Skills

Cross-functional teamwork

Excellent scheduling

Attention to detail

Independent work

GMP compliance

Calibration knowledge

Education

Associate degree in a technical discipline

Tools

Micro-Vu

Calibration software

Job description

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 JenaValve’s medical device quality management system.

Job Responsibilities

• 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 JenaValve Quality Management System in the performance of their duties.

Required Education And Experience

• 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.

Qualifications

Skills and Abilities Required for This Job

• 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 require high attention to detail.
• Ability to prioritize multiple tasks for efficiency.
• Must be able to perform routine work with minimal supervision and non-routine work with close supervision.
• Must be able to complete the applicable training requirements.
• Must understand GMP procedures and be able to work in a controlled cleanroom environment.
• Working knowledge of calibration and equipment qualification concepts preferred.

Physical Requirements

• Must be able to frequently stand, walk, bend, stoop, and kneel while performing maintenance and equipment support activities.
• Must be able to lift, carry, push, and pull tools, equipment, and supplies weighing up to 50 pounds without assistance, and heavier items with appropriate equipment or assistance.
• Must be able to work in a variety of environments, including manufacturing, cleanroom, and mechanical equipment areas, while wearing required personal protective equipment (PPE).
• Must possess sufficient visual acuity, manual dexterity, and hand-eye coordination to inspect, troubleshoot, calibrate, and maintain equipment.
• Must be able to respond to after-hours or weekend equipment alarms as needed.