Operations Processing Technician I

VIVEX Biologics, Inc.; Miami, Northern (FL, KY); Hybrid; USD 42,000 - 60,000; Full time

Job summary

VIVEX Biologics, Inc. in Florida is seeking an Operations Processing Technician I to support tissue processing and documentation for transplantation. The role ensures equipment and supplies are maintained and that Processing Room maintenance meets QA requirements.

You will assist with aseptic processing, allograft preparation, lyophilization, tissue treatment, and culture sampling, coordinating with the Processing Supervisor and cross functional teams.

Qualifications

• Bachelor’s degree in science or related with 0–1 year of experience or Associate degree with 1+ year experience.
• Tissue Banking experience preferred.
• Strong analytical, planning, critical thinking, and troubleshooting skills.
• Ability to effectively communicate with multidisciplinary teams.

Responsibilities

• Promotes Lean behaviors across the organization and leads related initiatives.
• Prepare aseptic processing and environmental setup per SOPs.
• Process allografts for clinical use (bone, soft tissue, skin, etc.) as directed.
• Daily prep, lyophilization, tissue treatment, and culture sampling per SOPs.
• Ensure QA compliance with federal/state regulations and AATB standards.

Skills

Analytical thinking

Troubleshooting

Documentation

Communication

Lean

Problem solving

Education

Bachelor’s degree in science or related

Associate degree with 1+ years of relevant experience

Job description

Job Purpose

The Operations Processing Technician I support the processing and documentation requirements of tissue during the cleaning, cutting, shaping, inspecting, and packaging operations for transplantation purposes. The Operations Processing Technician I is also responsible for ensuring that all equipment and supplies used for processing are maintained and ready for use, and that all Processing Room maintenance is completed daily while complying with Quality Assurance requirements as mandated by federal, state, and trade regulations.

Duties and Responsibilities

1. Promotes Lean behaviors across the organization (includes leading and participating in Try storming, Brainstorming and other Lean related initiatives)
2. Preparation of aseptic processing, environmental set-up including all equipment supplies and monitoring of sterile rooms as per SOP requirements.
3. Processing of all allografts for clinical use such as bone, soft tissues, skin, autografts and other tissues as instructed by Processing Supervisor, Team Lead or designee.
4. Daily activities include:

• Preparation and preservation of all types of bone, soft tissue, and birth tissue for cutting and shaping into allografts.
• Lyophilization
• Treatment of tissue with liquid nitrogen when applicable
• Tissue allograft
• Culture sampling and packaging as specified by SOPs.
• Decalcification of bone as applicable per SOPs.

5. Familiarity and knowledge of information contained in the Tissue Bank Manuals.

6. Applies Problem Solving Techniques and 5 WHY’s analysis to address Non-Conformities, Correction reports, and Customer Complaints as well as Technical Challenges by means of applying the root cause analysis process.

7. Ensures that Processing Operations comply to State and Federal Regulations and AATB Standards.

8. Driven by a challenging sense of urgency for customer delivery and Quality Standards during Processing.

9. Coordinates with Supporting Teams During the Process of Product Transfer for Execution of pilot runs at the Processing Stage.

10. Uses Judgment to Identify, Troubleshoot and resolve Day-to-Day Technical Operations Flow interrupters.

Requirements

Qualifications

Bachelor’s Degree in science or related with a minimum of 0-1-year relevant experience or Associate degree with 1 or more years of relevant experience. Tissue Banking experience Preferred. Strong analytical, planning critical thinking, and troubleshooting skills. Ability to effectively communicate with multidisciplinary teams.

Qualifications include:

• Computer Processing
• Lean Behaviors
• Problem Solving
• Strong Interpersonal and organizational skills
• Good documentation skills
• Written, Verbal and strong communication skills
• Attention to detail

Working Conditions

Majority of the work is performed indoors and in a cleanroom environment. Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary.

Physical Requirements

The ability to stand for extended periods of time. Occasional lifting/pushing heavy objects up to 50 pounds.

Direct Reports

No Direct Reports.