Sr Engineer, Process

Role: Senior Process Engineer supporting GMP vaccine manufacturing, primarily focusing on upstream/downstream operations, process troubleshooting, and process lifecycle management. Responsibilities include real-time troubleshooting on the manufacturing floor, root cause analysis, CAPA implementation, process improvements, and authoring GMP documentation. The engineer supports technology transfers, equipment qualification, validation activities, and partner with QA for regulatory compliance. The position involves collaboration with Manufacturing, MS&T, Quality, and Facilities teams, as well as vendor management and mentoring junior engineers. Qualifications: Bachelor's in Chemical, Biochemical, Mechanical or related Engineering discipline; 7–10+ years in GMP biopharma or vaccine manufacturing; hands-on experience with biologics or vaccine processes, including upstream/downstream operations, process validation, and data integrity principles. Preferred skills include knowledge of GMP regulations, process engineering documentation, and enterprise systems like AutoCAD, SAP. The role requires strong troubleshooting, cross-functional communication, and support for technology transfer and continuous improvement initiatives. High-value specifics: GMP vaccine manufacturing, biologics or vaccine modalities, process lifecycle ownership, validation, and regulatory compliance. Work setup: likely onsite with potential on-call support, specific travel not indicated.