Process Engineer III

Role: Process Engineer III supporting GMP biologics manufacturing at a new large molecule facility in Durham, NC. Responsibilities: oversee startup, installation, validation, and ongoing operation of bioprocess systems; support upstream/downstream equipment, maintain validated state, lead deviation investigations, and develop maintenance strategies. Collaborate with Operations, Quality, Validation, and MS&T; serve as SME during audits and inspections; mentor junior engineers and lead process improvement initiatives. Requirements: Bachelor's in Chemical, Mechanical, Electrical, or related engineering; minimum 5 years in pharmaceutical/biopharmaceutical GMP operations; experience with biologics, large molecule manufacturing, and stainless steel facilities; strong knowledge of FDA regulations, GMP, and validated systems; excellent communication and problem-solving skills. Preferred: experience with utilities (WFI, Clean Steam), startup activities, and technology transfer. High-Value: biologics, GMP manufacturing, upstream/downstream processing, large-scale stainless steel systems, regulatory compliance, FDA audits. Location: onsite in Durham, NC.