Process Engineer III

Role: Process Engineer supporting manufacturing processes in a GMP-regulated biopharma environment, with a focus on product line validation, equipment qualification, and troubleshooting. Responsibilities: lead process validation activities (Cleaning Validation, IQ/OQ/PQ), support production operations, troubleshoot material and equipment issues, support engineering change orders, design and qualify manufacturing equipment and fixtures, and assist in integrating new products into manufacturing. Requirements: Bachelor's in Engineering, Science, or related field; 5+ years' experience in process engineering within regulated environments; strong technical knowledge of GMP processes, validation, and equipment qualification; experience with medical devices, biologics, or pharmaceutical manufacturing. Preferred: higher education, extensive GMP process validation experience, particularly in Cleaning Validation and Equipment Qualification. High-Value: emphasis on GMP compliance, process validation (IQ/OQ/PQ), equipment qualification, and troubleshooting in biologics/pharmaceutical manufacturing. Work setup: not specified; likely on-site manufacturing environment.