Cleanroom Operator - GMP Lab, Start-Up Phase

Kuros Biosciences AG; Alpharetta, Northern (GA, KY); Hybrid; USD 26,000 - 33,000; Full time

Job summary

Kuros Biosciences AG is seeking a meticulous Operator to support the manufacturing of bone graft product families in a production laboratory and ISO Class 8 cleanroom. The role involves assembly, inspection, packaging, and documentation in compliance with GMP, ISO 13485, and FDA regulations.

Initial focus on validating and starting a new facility in Alpharetta, GA; on-site, full-time role. Typical schedule is Monday–Friday, 7:30 AM to 4 PM, with travel for on-the-job training.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering or related field required.
• Lean Six Sigma Green Belt Certification preferred.

Responsibilities

• Support the commencement of a new manufacturing facility in Alpharetta, GA.
• Perform manual and semi-automated assembly in ISO Class 8 cleanroom and controlled lab environments.
• Follow SOPs and batch records; ensure traceability and quality.
• Operate and maintain cleanroom equipment and tools; perform in-process inspections.
• Complete production documentation in compliance with FDA 21 CFR Part 820 and ISO 13485.
• Report deviations or equipment malfunctions to Quality promptly.
• Assist with training program development and continuous improvement initiatives.

Skills

Attention to detail

Communication

Stamina

Lean Six Sigma

ERP/MES systems (Dynamics 365)

Education

Bachelor’s degree in Biology, Chemistry, Engineering or related field

Tools

Microsoft Dynamics 365

Job description

Kuros Biosciences AG is seeking a meticulous Operator to support the manufacturing of bone graft product families in a production laboratory and ISO Class 8 cleanroom. The role involves assembly, inspection, packaging, and documentation in compliance with GMP, ISO 13485, and FDA regulations.

Initial focus on validating and starting a new facility in Alpharetta, GA; on-site, full-time role. Typical schedule is Monday–Friday, 7:30 AM to 4 PM, with travel for on-the-job training.