Bio-Manufacturing Support Tech I

Duties and Responsibilities

• Develop and maintain an understanding of relevant industry standards and regulations including but not limited to 21 CFR 820, 21 CFR 1271, AATB, MDSAP, and ISO 13485, ensuring compliance with these requirements across the organization.
• Maintain a safe, clean work environment and ensure proper disposal of hazardous and non-hazardous waste according to OSHA guidelines and SOPs.
• Adhere to SOPs, Good Documentation Practices (GDP), and safety protocols.
• Responsible for decontamination, cleaning, and environmental monitoring of the cleanroom areas and non-sterile equipment used to process donor tissue.
• Responsible for maintaining inventory of processing supplies/reagents and other materials 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 supplies into the cleanroom environment to maintain adequate inventory.
• Obtain environmental samples for surface, air, and water monitoring in conjunction with laboratory testing protocols.
• Assist with error investigations, and resolution, within the quality system.
• Assist in the preparation and transportation of soiled processing instruments, equipment, cleanroom garments, and biohazardous waste throughout the processing facility.
• Operate, monitor, and maintain lyophilizers (freeze-dryers) in accordance with the manufacturer’s recommendations and equipment-specific SOPs.
• Operate, monitor, and maintain autoclaves in accordance with the manufacturer’s recommendations and equipment-specific SOPs.
• Transport unprocessed donor tissue across campus.
• Know the appropriate storage conditions, locations, and tissue handling methods for unprocessed and processed donor tissue.
• Provide facility cleaning support to areas outside of the cleanroom environment.
• Responsible for decontamination, disinfection, cleaning, and sterilization of all non-disposable processing instruments and equipment.
• Manually wash processing instruments and equipment according to SOPs.
• Ensure all reusable tissue processing equipment and instruments are suitable for use, including inspection and assembly if applicable.
• Prepare relevant donor processing documentation, labels, and other consumable supplies for sterilization.
• Aseptically introduce equipment and supplies into the cleanroom environment.
• Safely operate, monitor, and maintain cleaning and sterilization equipment in accordance with manufacturer recommendations and equipment-specific SOPs.
• 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.
• Collect and prepare soiled cleanroom garments for shipment to vendor.
• Collect and prepare solid biohazardous waste for shipment in accordance with OSHA standards and SOPs.
• Aid and support other teams, departments, team leads, and supervisors as requested.
• Other duties as assigned.

Required Skills/Abilities

• Must be willing to acquire knowledge of FDA, ISO, and AATB regulations, as applicable.
• Develop an understanding of aseptic techniques and practices.
• Demonstrate capability to communicate effectively both orally and in writing.
• Ability to multitask and manage time efficiently.
• Ability to analyze information to draw relevant conclusions.
• Adapt to quickly changing priorities and schedules.
• Must possess excellent organizational skills and strong attention to detail.
• Must be able to reason independently and work with minimal guidance.
• Basic computer skills are required, such as knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary.
• Some experience with records maintenance and document control preferred.

Education & Experience

• High school diploma required.
• Willing to acquire Certified Tissue Bank Specialist (CTBS) certification.
• 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.