Clean Room Technician I

Shalby Advanced Technologies Inc; Springfield Meadows (CA); On-site; USD 28,000 - 39,000; Full time

Job summary

Shalby Advanced Technologies Inc. in California is seeking a detail-oriented Clean Room Technician responsible for daily cleaning, packaging and sterilization of implants and components to meet strict quality standards.

You will manage batching, labeling, and data entry for process control, maintain clean room equipment, and support compliance with GMP-like procedures while working in a fast-paced manufacturing environment.

Qualifications

• Able to lift 25 lbs regularly.
• Stand for 2+ hours per shift.
• Work with minimal supervision.
• Experience in fast-paced manufacturing preferred.

Responsibilities

• Perform daily cleaning, packaging and sterilization of implants and instrument subcomponents.
• Batching and assembling according to procedures and specifications; generate and inspect labels.
• Maintain and monitor clean room and CPS equipment; observe controlled environment standards.
• Assist with process data entry, staging, sealing and incubation of sterilization bags.
• Participate in corrective/preventive actions and complete compliance training.

Skills

Lifting 25 lbs

Standing 2+ hours

Attention to detail

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.