Pilot Technician I

POSITION SUMMARY:

Perform any one or all of the routine processes (e.g. dissection, layout, lyophilization, cutting, vialing, and or visual inspection) in a clean room laboratory setting according to established procedures and/or protocol guidelines. Produce high quality tissue products in an efficient manner. Ensure sterile processing and handling of tissue at all times. Perform regular inspection and cleaning of lab equipment to ensure equipment is in good, working order. Monitor equipment maintenance schedule to ensure routine and repair service is performed as needed. Perform data entry tasks and/or data verification.

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Perform custodial and administrative tasks to support co-tissue processors. Prepare, wash, and sterilize laboratory instruments, glassware, containers, etc. if required. Clean lab area, lab equipment, and handle hazardous waste removal, per standard operating and cleaning procedures. Ensure adequate supplies for gowning and sterile tissue processing are available in the lab at all times. Comply with all company policies, procedures, regulatory requirements and Good Documentation Practices (GDP).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform a variety of clean room, dish room, and/or lab area tasks with a focus on providing a sterile processing environment and supplies
• Perform dish room duties such as preparing, washing, and sterilizing lab instruments, glassware, containers, etc. using a heated container for steam sterilization (i.e. autoclave)
• Perform custodial duties to ensure the cleanroom, dish room, and lab area are clean and orderly at all times and maintain cleaning logs, per company standards, policies, and procedures
• Provide assistance to co-processors as requested (e.g. empty trash, dispose of biohazardous waste, bring them supplies, clean work areas throughout the day, etc.)
• Monitor lab and clean room supply levels to ensure adequate supplies for gowning, tissue processing, and instrument sterilization are available at all times
• Inspect instruments and supplies for defects, lot numbers, and expiration dates; ensure equipment in all areas are in proper working order

• Perform in-processing (e.g. at various stages such as dissection, layout, cutout, etc.) and final chart review; ensure all required documentation is present, matching donor ID's and lot numbers, etc. and correct or obtain information, as needed, based on study design
• Answer telephone calls and/or texts to provide information regarding status of work
• Process human tissue in an aseptic processing environment (lab) according to standard operating procedures and work instructions using surgical instruments and machinery when required
• Process donors adhering to standard operating procedures, redlined procedures, and/or feasibility / protocol study designs

• Perform any one or all of the routine tissue processes (e.g. dissection, layout, cutting, and vialing), as per required specifications, within expected processing times in order to meet project timelines
• Adhere to all policies and practices from the Quality Management System (QMS) based on company standards and regulatory standards for tissue processing
• Document results of each process performed, supplies used, etc. to maintain integrity and traceability of donor
• Support and contribute new ideas to the continuous tissue processing improvement efforts
• Perform all tasks listed above within a team setting, with clear communication between teammates to ensure project timelines are achieved
• During downtime of pilot tasks (between studies), technicians are required to be an asset within operations to ensure demand is being met and aligning with company goals Helping Humans Heal

EDUCATION/EXPERIENCE:

• High School Diploma
• Prefer BA/BS in Biology or Chemistry
• Minimum 6 months - 1 year in laboratory, biotech, pharma, medical or clean manufacturing
• Prefer knowledge of Good Documentation Practice (GDP), Good Tissue Practice (GTP), Good Manufacturing Practice (GMP) and AATB regulations

SKILLS/COMPETENCIES:

• Excellent oral, written, listening, and interpersonal communication skills
• Proficient in Microsoft Office (Word, Excel, etc.)
• Solid organization skills to support the efficiency of the laboratory operations
• Ability to effectively work and interact with all members of the laboratory, tissue processing, research & development, and tissue recovery functions
• Must show aptitude to develop appropriate skills needed for the job

WORK ENVIRONMENT:

The work is typically performed in a controlled laboratory, dish room, and/or laboratory environment. Wil use an autoclave and industrial dishwashers when required. Will have contact/exposure with biohazardous materials, chemicals, and blood and human tissue. Training will be conducted on the handling and safety practices necessary for the use and disposal of hazardous chemicals and potential biohazards. Will also be trained on all applicable equipment needed to perform the job.