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.

• 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.

• 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.