Engineer, Process - Drug Substance

Role: Process Engineer, Drug Substance supporting bioprocessing at a manufacturing site. Responsibilities: troubleshoot equipment issues, optimize utilities, support project planning and execution, ensure compliance with FDA GMP and quality systems, develop SOPs, participate in equipment validation, and collaborate across departments including Validation, Quality Control, Manufacturing, and Process Development. Qualifications: Bachelor's in related field with 2+ years of relevant experience or advanced degrees with less or no experience; project engineering experience preferred. High-Value: bioprocessing equipment, GMP compliance, validation, and cross-functional collaboration in biologics manufacturing. Work setup: not specified; physical requirements include lab and manufacturing environment.