Senior Process Engineer, Sterile

Role: Senior Process Engineer specializing in sterile manufacturing, responsible for transferring and scaling new products, ensuring process validation, compliance, and continuous improvement within a GMP environment. Responsibilities: develop and execute validation protocols, analyze manufacturing data, manage technical plans and project timelines, troubleshoot complex equipment/process issues, lead process start-ups, and serve as SME in aseptic, filling, packaging, formulation, lyophilization, and contamination control. Collaborates closely with R&D and manufacturing teams to ensure smooth process transfer from development to commercial scale, and validates sterilization and environmental systems. Requirements: BS in engineering, manufacturing, or related field; 5+ years in GMP sterile/aseptic manufacturing; strong knowledge of cGMP, FDA regulations; proven project management, problem-solving, and communication skills; proficiency with engineering software. Preferred: MS/MA in related disciplines. High-Value: expertise in sterile/aseptic processes, process validation, process improvements, and handling complex deviations. Work setup: on-site with travel required. Additional: OSHA-compliant respirator fit test required.