Illumina, Inc.
Calibration Engineers ( 2 -Sr Level) (Finance)
The Calibration Engineer is part of the Equipment Lifecycle Management Team who provides expertise, service, and support to San Diego Illumina headquarters by assuring equipment calibration compliance at world class levels in a fast pace regulated environment and providing high level reliability exceeding Illumina's dynamic development and manufacturing demands. Calibration Engineers will support the day to day manufacturing equipment maintenance operations by owning high complexity maintenance task and challenges, with minimal supervision. This individual will work in a dynamic team-oriented environment that supports multiple operations and technologies helping Illumina deliver its highly complex product pipeline in a reliable and sustainable manner.
Responsibilities:
Able to lead investigation and resolution of technical problems within own discipline, with oversight.
Able to manage vendors and contractors on a technical level for calibration services and preventative maintenance.
Support remediation efforts related to calibration. This includes an assessment of our calibration program and identify any gaps as well as supporting continuous improvement initiatives.
Develop solutions to minimize calibration processing time.
Recommend calibration standards and IM&TE.
Perform corrective actions and assist with out of tolerance (OOT) investigations
Contributes ideas for functional development, and supports efforts driven by others.
Contributes to investigation and resolution of technical problems.
Generate standard operating procedures/work instructions.
Influences decisions in own area of responsibility.
Plan, prioritize, coordinate, and execute multiple parallel activities like calibrations, supplier scheduling, and project activities with minimal guidance from manager or lead.
Provides supporting data on risk and recommendations in area of responsibility and at critical interfaces to other cross functional teams.
Work in a team environment to improve equipment calibration program.
While performing the duties of this job, is regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, or wear safety gear. Must regularly lift and / or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.
Requirements:
Experience calibrating equipment in regulated environments such as; scales/balances, thermometers, temperature & humidity chambers, dimensional equipment, mass, force, dewpoint, pressure/vacuum, time, velocity, ovens, refrigerators/freezers, differential pressure, etc.
Experience reviewing calibration documentation for accuracy and compliance
Experience generating reports, adding records, updating histories, and performing data entry into a Calibration Management System
Experience installing, troubleshooting, adjusting, and repairing measuring equipment
Experience maintaining calibration test equipment
Working knowledge of relevant industry guidelines: ISO-13485, ANSI-Z540 or ISO-17025
Experience determining calibration requirements for IM&TE
Ability to operate in a fast pace environment and adapt to changes in priority.
Ability to use Microsoft Office and Windows
Excellent math and analytical skills
Excellent verbal and written documentation skills in English
Experience working in a clinically regulated environment is highly desirable
Experience working on laboratory equipment preferred
Good data collection, hands-on skills, and able to summarize results
Good technical troubleshooting skills and mechanical aptitude
Knowledge of GMP (Good Manufacturing Practice) (preferred)
SAP ERP system experience (preferred)
Work experience in Life Sciences / Pharmaceutical / Medical Devices industries would be an advantage
Travel up to 10%
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Experience/Education:
Min 2 years of related experience with a bachelor's degree/Master's degree; or equivalent work experience.