US Operator

Overview

We are seeking a meticulous and quality minded Operations Technician that works in a production laboratory and/or cleanroom setting to support the manufacturing of our bone graft product families. The technician will perform assembly, inspection, packaging, and documentation tasks in accordance with GMP, ISO 13485, and FDA regulations. This role is critical to ensuring product quality, traceability, and compliance throughout the production process.

In the beginning, this role will support the validation and commencement of our new manufacturing facility in Alpharetta, Georgia. This is a full‑time/hourly, onsite position with a pay rate of $24.04 per hour.

• Support the commencement of our new manufacturing facility in Alpharetta, Georgia, including travel to our Bilthoven, Netherlands manufacturing location for on‑the‑job training and knowledge transfer.
• Support the execution of our IQ/OQ/PQ validation process prior to the go‑live of our new manufacturing.
• Support the development and continuous improvement of our training program.
• Perform manual and semi‑automated assembly of our Magnetos product family in an ISO Class 8 cleanroom and controlled laboratory environment.
• Follow detailed work instructions, standard operating procedures (SOPs), and batch records accurately.
• Operate and maintain cleanroom equipment and tools (e.g., graduated cylinders, vibration tables, scales, vacuum sealers, ovens, dispensers).
• Perform in‑process inspections to verify quality specifications.
• Handle sterile or non‑sterile packaging and labeling of finished products, ensuring lot control and traceability.
• Maintain cleanroom gowning protocols and adhere strictly to contamination control and hygiene standards.
• Accurately complete production documentation, including batch records, in compliance with FDA 21 CFR Part 820 and ISO 13485.
• Report deviations, non‑conformances, or equipment malfunctions to quality personnel promptly.
• Support cleaning, calibration, and routine maintenance of equipment and cleanroom areas.
• Collaborate with Quality, Process Development Engineering, R&D and Production teams on continuous improvement initiatives and process validations.

• Education:
  • Bachelor’s degree in Biology, Chemistry Engineering, Biology, or related field required.
  • Lean Six Sigma Green Belt Certification preferred.
• Experience:
  • 0-2+ years in Operations within an ISO
    13485 regulated industry.
  • Experience working in an ISO 7 or ISO 8 cleanroom manufacturing process.
  • Experience working with lean manufacturing principles and in a 6S program.
• Skills:
  • Strong attention to detail and ability to follow precise work instructions.
  • Excellent communication and interpersonal abilities.
  • Ability to stand for up to 8 hours per day.
  • Understanding of lean methodologies, Six Sigma tools and working within a 6S program.
  • Proficiency in an ERP or MES system, preferably Microsoft Dynamics 365.

Ability to travel domestic and international.

• Mobility & Posture: May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
• Lifting/Carrying: May require lifting and carrying items 50 pounds or more.
• Manual Dexterity: Frequent use of hands and fingers for typing, writing, grasping, and operating office or job‑specific equipment.
• Driving: Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver’s license.

• Listing on the SIX Swiss Exchange under the symbol KURN since 2016.
• A commercial & research footprint that spans >20 markets.
• Dozens of clinical and scientific expert advisers.
• >25 orthobiologics‑related patents.
• >400 patients evaluated in Level I, randomized controlled clinical trials.
• >20 well‑controlled Level I‑IV clinical trials initiated, including 6 that are complete.
• Published Level I evidence published in Spine.

Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros Biosciences complies with GDPR the California Consumer Privacy Act (CCPA).

View our CCPA Notice here.