Bio-Manufacturing Support Technician

1 month ago

Belgrade, Maine, United States Xtant Medical Holdings Inc Full time
About the Role

Xtant Medical Holdings Inc is seeking a highly skilled Bio-Manufacturing Support Technician to join our team in Belgrade, MT. As a key member of our team, you will play a critical role in ensuring the quality and safety of our medical devices and human tissues for transplants.

Responsibilities
  • Decontaminate and clean cleanroom areas and non-sterile equipment used to process donor tissue
  • Maintain inventory of processing supplies and materials within the cleanroom environment
  • Ensure supplies are acceptable for processing use and stock is rotated using the First-In First-Out 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 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
  • Prepare relevant donor processing documentation, labels, and other consumable supplies for sterilization
  • 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 when handling biological material
  • Collect and prepare soiled cleanroom garments for shipment to vendor
  • Collect and prepare solid biohazardous waste for shipment in accordance with OSHA standards and Xtant SOPs
Requirements
  • High School Diploma or equivalent required
  • Must be willing to acquire Certified Tissue Bank Specialist (CTBS) certification
  • Some familiarity with basic laboratory techniques and equipment, aseptic practices preferred but not required
  • Experience working in sterile environments, healthcare or medical device production preferred but not required
  • Experience with records maintenance and document control preferred but not required
  • Basic computer skills required, including knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
  • Must have excellent manual dexterity and good eye/hand/foot coordination
  • Must be able to perform repetitive tasks/motions
  • Must be able to record information legibly by hand
  • Must be able to lift, push, and pull 60 lbs
Working Conditions
  • Working conditions include normal office environment, environmentally controlled areas (ECAs), cleanrooms, and decontamination areas
  • May require evening work and weekend work
  • May require 4+ hours of continuous standing
  • May work in conditions leading to minor personal discomfort such as in temperatures above or below personal comfort levels
Health and Safety
  • Duties will include direct contact with human tissue, blood, bone, and fluids
  • 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
  • Hepatitis B vaccine is highly recommended and provided to employees who may have contact with human tissue at no cost to the employee. Any employee who declines a Hepatitis B vaccine will be required to sign a waiver

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