Title: Manufacturing Engineer
Location: Buffalo, NY (100% Onsite)
Duration: Long-term Contract (12+ Months)
Start Date: ASAP
Role Overview:
We are seeking an experienced Manufacturing Engineer with strong expertise in Hot Melt Extrusion (HME) to support operations within a CDMO / GMP-regulated in-house testing and manufacturing environment.
Key Responsibilities & Experience:
Provide hands-on manufacturing engineering support for Hot Melt Extrusion (HME) processes.
Extensive experience with HME extrusion, involving the blending of Active Pharmaceutical Ingredients (APIs) with polymer matrices.
Strong understanding of thermal and mechanical energy application to achieve uniform API dispersion and product consistency.
Support process optimization, troubleshooting, and scale-up activities within a GMP environment.
Collaborate closely with quality, validation, and development teams to ensure compliant manufacturing operations.
Required Background:
Proven experience in HME manufacturing or process engineering.
Experience working in CDMO and GMP-regulated pharmaceutical environments.
Strong knowledge of in-process controls, material behavior under heat, and extrusion parameters.
