Assembly Process Engineer

Assembly Process Engineer - North Carolina - 12-month contract

Join a landmark project as QCS partner with our client a global biologics organization to drive delivery of a cutting-edge facility in North Carolina. Be part of a large-scale investment and play a pivotal role in bringing this world-class program to life.

What you'll do: 

• Act as system owner for device assembly lines (e.g., auto‑injectors), defining assembly steps, tolerances, and in‑process controls for high‑speed operations.
• Plan and execute FAT/SAT covering feeding, joining, torque/force checks, and vision systems; confirm line balance and error‑proofing.
• Oversee installation/start‑up and integration with packaging/labeling modules; troubleshoot mechanical and control issues to meet yield and availability targets.
• Lead qualification and documentation (protocols, deviations, turnover packages), sustaining GMP compliance through ramp‑up.

What you'll need: 

• Previous experience serving as an Owner’s Representative.
• Extensive experience in medical device assembly engineering
• Proven delivery of FAT/SAT, commissioning, and qualification with robust in‑process controls (vision, torque/force, error‑proofing) under GMP.
• Vendor and cross‑functional coordination skills; full‑time on‑site presence in North Carolina.

If this role is of interest, apply today! 

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