Description
SaniSure is hiring a Quality Engineer to support the manufacturing of single-use bioprocessing components, tubing, molded components, and assemblies used in biopharmaceutical production. The role leads quality investigations, root cause analysis, CAPA, change control, risk assessments, customer and supplier audits, regulatory inspections, process improvements, and manufacturing quality systems. The engineer will work with Operations, Manufacturing Engineering, R&D, Supply Chain, Regulatory, and other cross-functional teams, and will support cleanroom assembly, extrusion, molding, packaging, sterilization, validation, and lot traceability. A bachelor’s degree in engineering, biological sciences, bioprocess engineering, chemistry, or a related technical field and at least five years of quality operations experience in biotechnology, pharmaceutical, medical device, or single-use technology manufacturing are required.
