Clean Room Technician I
About The Position
The Clean Room Technician is responsible for daily cleaning, packaging and sterilization (CPS) operations, including scheduling, batching, staging, assembly, monitoring and cleaning of product. The position also performs routine maintenance of production-area equipment, including the clean room and CPS equipment. The role performs quality-system functions in accordance with documented procedures. These include batching and assembling implant and instrument subcomponents; processing production and rework routers; generating and inspecting product labels; cleaning implants and instruments and inspecting their cleanliness; staging and sealing components in Tyvek pouches and polyethylene bags and inspecting pouch seals; and sterilizing implants while completing process steps, data collection and entry, staging and sealing sterilization bags, and incubating biological indicators. Additional duties include staging packaging components and boxing implants; following controlled-environment requirements for gowning, segregation and hygiene; maintaining cleaning, packaging and sterilization equipment; obtaining DI water samples to verify controlled-environment specifications; performing limited purchasing under the direction of the Lead Clean Room Technician; participating in corrective and preventive action resolution; completing required compliance and regulatory training; and performing other duties assigned by management.
Requirements
- Ability to lift 25 lbs. on a recurring basis.
- Ability to stand for more than two hours at a time.
- Ability to work with little or no supervision.
- Excellent communication and organizational skills, with extremely strong attention to detail.
- Proficiency with computers, including Microsoft Office products.
Nice To Haves
- Experience working in a fast-paced manufacturing environment is preferred.
Responsibilities
- Schedule, batch, stage, assemble, monitor and clean product as part of daily CPS operations.
- Perform routine maintenance of production-area equipment, including clean room and CPS equipment.
- Batch and assemble implant and instrument subcomponents according to documented procedures and engineering specifications.
- Process production and rework routers; generate and inspect product labels.
- Clean implants and instruments and inspect product cleanliness after cleaning.
- Stage and seal components in Tyvek pouches and polyethylene bags; inspect pouch seals.
- Sterilize implants and complete required process steps, including data collection and entry, staging and sealing sterilization bags, and incubation of biological indicators.
- Stage required packaging components and box implants.
- Observe controlled-environment specifications, including gowning, segregation and hygiene requirements.
- Maintain cleaning, packaging and sterilization equipment.
- Obtain DI water samples to verify controlled-environment specifications.
- Perform limited purchasing duties under the direction of the Lead Clean Room Technician.
- Participate in resolving corrective and preventive actions as needed for the quality system.
- Complete required compliance and regulatory training.
- Perform additional duties or assignments as required by management.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
