K
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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Get started — it's freeOperations Technician
Kuros Biosciences · Alpharetta
