Clean Room Technician I

Shalby Advanced Technologies, Inc; Cameron Park (CA); On-site; USD 28,000 - 41,000; Full time

Job summary

Shalby Advanced Technologies, Inc. is seeking a Clean Room Technician in California to perform daily cleaning, packaging and sterilization within CPS operations.

Responsibilities include batching, assembly, labeling, sterilization, environmental controls, data entry and basic purchasing tasks under supervision. Candidates should have strong attention to detail, communicate well, and be able to lift 25 lbs and stand for long periods.

Qualifications

• Excellent communication and organizational skills.
• Extremely strong attention to detail.
• Proficient with Microsoft Office products.

Responsibilities

• Cleaning of implants and instruments; packaging and sterilization of CPS equipment.
• Batching and assembly of product components per procedures and specs.
• Processing of production and rework routers; generation and inspection of product labels.
• Staging and sealing of components; pouch seal inspection.
• Sterilization of implants; data collection and process data entry.
• Observance of controlled environment requirements including gowning and hygiene.
• Assist with limited purchasing under supervision.
• Participate in corrective/preventive actions as needed.
• Complete required compliance and regulatory training.

Skills

Communication skills

Organizational skills

Attention to detail

Microsoft Office

Tools

Microsoft Office

Job description

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

• 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.