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Kuros Biosciences · 10 hours ago

US Operator

Full-time

Onsite

New Grad, Entry Level

$40K/yr - $50K/yr

0+ years exp

Kuros Biosciences is a Swiss-headquartered biotech company focused on advancing bone healing through high-quality scientific evidence. They are seeking an Operations Technician to support the manufacturing of bone graft products, ensuring compliance with GMP, ISO 13485, and FDA regulations.

BiopharmaBiotechnologyHealth CareMedical

Responsibilities

Support the commencement of our new manufacturing facility in Alpharetta, Georgia. This includes but not limited to:

Traveling 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 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 lab 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

Qualification

ISO 13485 experienceLean Six Sigma Green BeltCleanroom manufacturingERPMES systemsLean manufacturing principlesAttention to detailCommunication skillsInterpersonal abilities