Bio-Manufacturing Support Technician

4 hours ago

Belgrade, Montana, United States Xtant Medical Holdings Inc Full time
About Xtant Medical Holdings Inc

Xtant Medical Holdings Inc is a leading manufacturer of medical devices and human tissues for transplants. Our mission is to improve the quality of life for our patients by designing, manufacturing, and distributing safe, effective, and high-quality medical devices and tissues.

Job Summary

We are seeking a highly skilled Bio-Manufacturing Support Technician to join our team on-site in Belgrade, MT. The successful candidate will be responsible for maintaining a clean and safe environment in our cleanroom areas, ensuring the proper handling and processing of biological materials, and supporting the production of high-quality medical devices.

Key Responsibilities
  • Decontaminate and clean cleanroom areas and non-sterile equipment used to process donor tissue
  • Maintain inventory of processing supplies and reagents within the cleanroom environment and other areas throughout the processing facility
  • Ensure supplies are acceptable for processing use and stock is rotated using the First-In First-Out (FIFO) method
  • Aseptically transfer equipment and supplies into the cleanroom environment
  • Obtain environmental samples for surface, air, and water monitoring in conjunction with laboratory testing protocols
  • Assist with preparation and transportation of soiled processing instruments, equipment, cleanroom garments, and biohazardous waste throughout the processing facility
  • Operate, monitor, and maintain cleaning and sterilization equipment, lyophilizers, and autoclaves in accordance with the manufacturer's recommendations and equipment-specific SOPs
  • Decontaminate, disinfect, clean, and sterilize (where appropriate) all non-disposable processing instruments and equipment
  • Ensure all reusable tissue processing equipment and instruments are suitable for use, including inspection and assembly
  • Safely prepare and handle cleaning reagents and solutions according to SDS and SOPs and follow OSHA bloodborne pathogen standards, Universal Precautions, and current Good Tissue Practices (cGTP) when handling biological material
Requirements
  • Some familiarity with basic laboratory techniques and equipment, aseptic practices is preferred, but not required
  • Experience working in sterile environments, healthcare or medical device production is preferred, but not required
  • Experience with records maintenance and document control is preferred, but not required
  • Basic computer skills are required, such as knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
Working Conditions

The successful candidate will work in a normal office environment, environmentally controlled areas (ECAs), cleanrooms, and decontamination areas. May require evening work and weekend work. Shift times may vary depending on the needs of the department. Employee's shift will be subject to change based on those needs.

Must adhere to all health and safety requirements specified when entering processing, device manufacturing areas, and decontamination areas and in the handling of company products. This position will be required to wear personal protective equipment (PPE), including but not limited to scrubs, laboratory coat, gloves, face shields, helmets, boot covers, and sterile suits. Will require training in the routine handling of chemicals and biohazards. Will require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable.

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