About the Job

This position supports Ossium Health’s Clinical Production group by performing tasks related to the preparation of human tissue products for clinical use. The role involves executing production activities according to standard operating procedures (SOPs) within an ISO 7 cleanroom environment. The Tissue Product Operator performs processes in compliance with regulatory and quality standards, demonstrating strong aseptic technique, attention to detail, and effective communication with peers and management.

Required Qualifications

• High school diploma
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and time management in a dynamic startup environment
• High level of attention to detail in checking work and information for accuracy and quality
• Reliable and able to produce consistent, high quality work
• Great work ethic, positive attitude, and ability to work as part of a team

Preferred Qualifications

• Hands on laboratory experience working in a biological safety cabinet, pipetting, preparing reagents, and using lab equipment
• Experience working in a cleanroom environment, research laboratory, cell therapy, tissue banking, blood banking, or a closely-related industry

Key Responsibilities

• Perform production tasks in accordance with cGMPs as an operator or verifier in the production of tissue products within an ISO 7 cleanroom environment. Tasks include tissue receipt, tissue preparation, aseptic processing, and completion of all documentation in real time.
• Maintain cleanrooms and production suites, including routine and non-routine cleaning of biological safety cabinets, cleanroom areas, and equipment; perform environmental monitoring and support continuous equipment monitoring.
• Prepare processing reagents as needed and manage material flow to and from the cleanroom, maintaining accurate inventory in the electronic inventory system.
• Collaborate with coworkers and supervisors to troubleshoot equipment or process issues, applying strong critical thinking and communication skills.
• Participate in technology transfer and process improvement activities related to new or enhanced tissue production processes in the manufacturing facility.

Physical Requirements

• Must be able to work in a moderately noisy environment
• Must be able to work around biohazardous materials and chemicals
• Required to work the majority of the shift aseptically in a controlled environment with limited breaks. This environment requires special gowning (ie. over the head, face, hands, feet and body).
• Must be able to lift, push, pull and/or carry up to 50 lbs
• Must have sufficient manual dexterity, hand/finger coordination, wrist mobility, wrist stability, and grip strength to handle, feel, grasp, manipulate, and operate objects, manual and power tools, equipment, and controls safely and accurately.
• Regularly required to sit, stand, walk, squat, balance, climb, stoop, kneel, crouch and reach with arms.

A pre-employment physical examination is required for this position. This examination will be conducted after a conditional offer of employment has been extended and will evaluate the candidate's ability to safely perform the essential functions listed above.

Schedule

• Full-time (40 hours per week) onsite in our Indianapolis facility
• This is an hourly, non-exempt role that is eligible for overtime
• 8 hour shifts, Monday through Friday
  • 8AM start time during training
• Some holiday and overtime work required