Operations Technician – Production Laboratory (Alpharetta, GA)

About the role

We are looking for a meticulous Operations Technician to work in a production laboratory and clean‑room environment supporting the manufacturing of bone‑graft products. The role is based in Alpharetta, Georgia and will help launch our new facility while ensuring compliance with GMP, ISO 13485 and FDA regulations.

Key responsibilities

• Support the start‑up of the new Alpharetta manufacturing site, including travel to the Netherlands for on‑the‑job training.
• Assist with IQ/OQ/PQ validation activities prior to go‑live.
• Perform manual and semi‑automated assembly of Magnetos product family in an ISO Class 8 cleanroom.
• Follow work instructions, SOPs and batch records, and operate cleanroom equipment such as graduated cylinders, vibration tables, scales, vacuum sealers, ovens and dispensers.
• Conduct in‑process inspections, handle sterile and non‑sterile packaging, and maintain lot traceability.
• Document production activities in compliance with FDA 21 CFR 820 and ISO 13485, reporting deviations promptly.
• Support equipment cleaning, calibration, routine maintenance and cleanroom gowning protocols.
• Collaborate with Quality, Process Development, R&D and Production teams on continuous‑improvement and process validation projects.

Required profile

• Bachelor’s degree in Biology, Chemistry, Engineering or a related field.
• 0–2 years of experience in an ISO 13485 regulated environment, preferably in a cleanroom (ISO 7/8).
• Familiarity with lean manufacturing, 6S and Six Sigma methodologies; Green Belt certification is a plus.
• Ability to stand up to 8 hours per day and travel domestically and internationally as needed.

Required skills

• Operation of cleanroom equipment (scales, vacuum sealers, ovens, etc.).
• Use of ERP/MES systems, preferably Microsoft Dynamics 365.
• Lean Six Sigma tools and 6S program experience.
• Understanding of GMP, ISO 13485 and FDA 21 CFR 820 documentation requirements.