Reporting to the Shift Supervisor or Process Supervisor, the Operator is responsible for monitoring the system which includes observing pressure, temperature and relative humidity measurements on charts or computer monitors. Ensures that product is moved through the facility at the appropriate times. Responsibilities Responsible for operation of the plant in the absence of the Shift Supervisor and/or Process Supervisor. Monitors system which includes: Observing pressure, temperature and relative... more details
Reporting to the Shift Supervisor or Process Supervisor, the Operator is responsible for monitoring the system which includes observing pressure, temperature and relative humidity measurements on charts or computer monitors. Ensures that product is moved through the facility at the appropriate times.
Responsibilities
Responsible for operation of the plant in the absence of the Shift Supervisor and/or Process Supervisor.
Monitors system which includes:
Observing pressure, temperature and relative humidity measurements on charts or computer monitors.
Turning valves and adjusting controls to ensure the safe operation of the equipment.
Observing sterilizers and auxiliary units to detect malfunctions and assisting with repairs as needed.
Documenting and recording process readings.
Reports any damaged product to the Shift Supervisor or Process Supervisor.
Reports system problems to the Maintenance Supervisor or Maintenance Technician.
Performs some daily and weekly equipment preventative maintenance tasks and may assist Maintenance as required.
Stores and removes chemicals used in processing in accordance with established procedures and laws.
Participates on plant safety committees and follows all established safety rules and regulations.
Assists with other tasks as assigned by Supervisor.
SUPERVISION GIVEN: Oversees the work of Process Assistant Operators.
Qualifications
High School Diploma or equivalent combination of education and experience.
Minimum of six (6) months to one (1) year of experience working in a sterilization environment desired.
Must be able to read, write and speak fluent English.
Must be able to add, subtract, multiply and divide in all units of measure using whole numbers, fractions and decimals.
Must be willing to work established shifts.
Must be able to lift a minimum of 50 pounds and perform repetitive bending and lifting motions over a period of time.
Must have forklift driving experience.
Computer skills desired.
Special Requirements:
Must possess a thorough understanding of US FDA Quality Systems Regulations and ISO 9000 regulations
Understanding of AAMI, EN and ISO guidelines for EO sterilization of medical devices is desirable
Knowledge and experience working with the US and International requirements for medical devices is essential
Knowledge of regulatory affairs for a FDA registered medical device or pharmaceutical manufacturer and direct experience with conducting or participating in FDA or supplier audits
Experience with a company using EO sterilization of products is desirable
Experience in document control to satisfy all ISO 9000 and FDA Quality System requirements
Must be medically approved for respirator use (EO)
Must be able to tolerate exposure to high temperatures and high humidity (120F and 60% RH for 20 minutes) (EO)
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities.
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