Operator – Production Laboratory (Alpharetta, GA)

About the role

We are looking for a meticulous Operator to join our production laboratory and clean‑room team in Alpharetta, GA. The role supports the launch of a new manufacturing facility for bone‑graft products, ensuring strict compliance with GMP, ISO 13485, and FDA regulations.

Key responsibilities

• Travel to the Netherlands site for on‑the‑job training and knowledge transfer.
• Assist with IQ/OQ/PQ validation activities before the facility goes live.
• 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 such as graduated cylinders, vibration tables, scales, vacuum sealers, ovens, and dispensers.
• Conduct in‑process inspections and ensure product traceability.
• Handle sterile and non‑sterile packaging and labeling, adhering to lot control procedures.
• 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, and equipment issues to quality personnel.
• Support equipment cleaning, calibration, and routine maintenance.
• Collaborate with Quality, Process Development, R&D, and Production teams on continuous‑improvement projects.

Required profile

• Bachelor’s degree in Biology, Chemistry, Engineering, or a related field.
• 0–2+ years of experience in an ISO 13485‑regulated manufacturing environment.
• Experience working in ISO 7 or ISO 8 cleanroom processes.
• Familiarity with lean manufacturing principles and 6S programs.
• Lean Six Sigma Green Belt certification preferred.

Required skills

• Microsoft Dynamics 365 (ERP/MES) proficiency.
• Lean manufacturing methodology.
• Six Sigma tools (Green Belt).
• ERP and MES system usage.
• Cleanroom equipment operation.

What we offer

• Full‑time, hourly position (Monday‑Friday, 7:30 AM‑4:00 PM).
• Competitive pay rate of $24.04 per hour.
• Opportunity to work on the launch of a state‑of‑the‑art manufacturing facility.
• Professional development through training and validation projects.