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. Responsibilities 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. Qualifications 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. #J-18808-Ljbffr Quanta Consultancy Services Ltd