Filling Process Engineer - North Carolina - 12-month contractJoin 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:
- Serve as system owner for syringe filling lines, driving design compliance, ergonomics, and throughput targets across machine centers and infeed/outfeed modules.
- Develop and run FAT/SAT protocols covering dosing accuracy, reject handling, and environmental controls; validate recipe/phase logic with automation.
- Manage installation, start‑up, and troubleshooting, coordinating vendors and plant teams to achieve stable, compliant operation.
- Prepare qualification packages and acceptance reports; resolve deviations and finalize turnover to operations.
What you'll need:
- Previous experience serving as an Owner’s Representative.
- Extensive experience in aseptic fill/finish engineering with hands‑on syringe or vial filling equipment and environmental control strategies.
- Track record delivering FAT/SAT, commissioning, and qualification under GMP, including recipe/phase verification.
- Strong problem‑solving, vendor management, and documentation skills; full‑time on‑site presence in North Carolina.
If this role is of interest, apply today!
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