Operations Technician at Kuros Biosciences - ScoutJobs - The AI-curated global job board
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Posted 20 hours ago

Operations Technician

Kuros Biosciences

Requirements

Bachelor's degree in Biology, Chemistry, or Engineering, Experience in ISO 13485 regulated industry, Cleanroom manufacturing experience, Lean manufacturing knowledge, ERP/MES proficiency

Skills

ISO 13485cleanroomLean Manufacturing

About the role

Responsibilities

  • Support the commencement of the new manufacturing facility in Alpharetta, Georgia
  • Travel to the Bilthoven, Netherlands location for on-the-job training and knowledge transfer
  • Support the execution of IQ/OQ/PQ validation processes
  • Perform manual and semi-automated assembly of Magnetos product family in an ISO Class 8 cleanroom
  • Follow detailed work instructions, SOPs, and batch records accurately
  • Operate and maintain cleanroom equipment including graduated cylinders, scales, and vacuum sealers
  • Perform in-process inspections to verify quality specifications
  • Handle sterile and non-sterile packaging and labeling with strict lot control
  • Maintain cleanroom gowning protocols and contamination control standards
  • Complete production documentation in compliance with FDA 21 CFR Part 820 and ISO 13485
  • Report deviations, non-conformances, or equipment malfunctions promptly
  • Collaborate with Quality, Engineering, and R&D teams on continuous improvement

Requirements

  • Bachelor’s degree in Biology, Chemistry, Engineering, or a related field
  • 0-2+ years of operations experience within an ISO 13485 regulated industry
  • Experience working in an ISO 7 or ISO 8 cleanroom manufacturing process
  • Experience with lean manufacturing principles and 6S programs
  • Proficiency with ERP or MES systems (Microsoft Dynamics 365 preferred)
  • Ability to stand for up to 8 hours per day
  • Ability to travel domestically and internationally

Preferred Qualifications

  • Lean Six Sigma Green Belt Certification

About the Company

Kuros is a Swiss-headquartered biotech company focused on advancing bone healing through high-quality scientific evidence and orthobiologics. The company is listed on the SIX Swiss Exchange and maintains a global footprint across more than 20 markets.

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Operations Technician

Kuros Biosciences · Alpharetta

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