Senior Equipment Engineering Technician

Caris Life Sciences•Phoenix, AZ

2d•Onsite

About The Position

The Senior Equipment Engineering Technician installs, maintains, and repairs equipment, performs routine checks, and troubleshoots technical issues to ensure optimal performance and safety. This role supports the Equipment Engineering Supervisor in assisting with project management, developing maintenance strategies, as well as training new Equipment Engineering Technicians. This position is also responsible for assisting in company-wide regulatory compliance to all applicable regulatory requirements and assisting with the day-to-day operations of the laboratory equipment program.

Requirements

Bachelor’s degree in biological science, engineering, or similar field.
A minimum of 3 years of experience working within an FDA-regulated laboratory, medical device, or pharma environment.
Familiar with ISO13485, ISO9001, CAP/CLIA, and FDA regulations/requirements
Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.
Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification.

Nice To Haves

A certification by the American Society for Quality (ASQ) or equivalent.
Previous experience in a laboratory (next generation sequencing or related field) or quality assurance role is preferred.

Responsibilities

Participate in internal and external audits.
Manage company records in accordance with regulatory requirements and company policies.
Author, review, revise, and implement standard operating procedures (SOP’s) for the QMS.
Analyze and implement improvements in equipment management processes to increase scalability and consistency of performance. Develop associated programs and create job aides.
Capture, trend, analyze quality data, and identify areas for improvement.
Be involved in the resolution of Nonconformances (NONC) and Corrective Action Preventive Action (CAPA) events.
Collaborate with the cross-functional teams to achieve defined business objectives.
Use creative problem-solving skills to identify, solve, or improve processes.
Review records for accuracy.
Utilize the Master Site Validation Plan to minimize logistical challenges in completing equipment tasks.
Coordinate with approved vendors to perform equipment calibrations, preventative maintenance, and repairs.
Perform equipment repairs, calibrations, and/or maintenance as required.
Prepare, coordinate, and lead training of Equipment Engineering Technicians and/or members of other departments.
Other duties as assigned