Clean Room Technician I

Description

The Clean Room Technician is responsible for daily cleaning, packaging and sterilization (CPS) operations including: Scheduling, batching, staging, assembly, monitoring and cleaning of product. In addition to routine maintenance of production area equipment including clean room and all CPS equipment.

The Clean Room Technician is responsible for performance of the following quality system functions in accordance with documented procedures:

Batching and assembly of implant and instrument subcomponents in accordance with documented procedures and engineering specifications.

Processing of production and rework routers. Generation and inspection of product labels.

Cleaning of implants and instruments. Inspection of product cleanliness after cleaning.

Staging and sealing of components in Tyvek pouches and polyethylene bags. Pouch seal inspection.

Sterilization of implants. Following all process steps, including data collection, process data entry, staging and sealing of sterilization bags, incubation of biological indicators.

Staging of necessary packaging components and implant boxing.

Observance of the controlled environment specifications including gowning, segregation and hygiene requirements, and maintenance of the cleaning, packaging and sterilization equipment.

Obtaining and DI water samples for verification of controlled environment specifications.

Perform limited purchasing duties as required, under direction of Lead Clean Room Technician.

Participation in resolution of corrective / preventive action, as necessary for proper functioning of the quality system.

Complete all required compliance and regulatory training.

Perform additional duties/assignments that may be required by management from time to time.

Requirements

This position requires the following qualifications (at a minimum):

Ability to lift 25 lbs. on a recuring basis.

Ability to work standing for 2+ hours at a time.

Ability to work with little or no supervision.

Experience working in fast-paced manufacturing environment is preferred.

Excellent communication, organizational skills and extremely strong attention to detail.

Proficient in computer knowledge, including Microsoft Office products.