Senior Engineer, Sterilization and Environmental is responsible for planning, coordinating and directing the quality assurance program designed to ensure continuous compliance with regulations regarding sterilization and environmental activities consistent with established standards. This position reports to the Sterilization and Biocompatibility Manager and is part of the Quality Assurance team located in Tijuana, Baja California, México and will be an on-site role. In This Role, You Will: Conduct periodic and special validations of sterilization processes (Radiation and EtO) at the manufacturing facility, including coordinating samples, shipping, laboratory testing, and documenting results according to ISO 11137 and ISO 11737. Review and track sterilization results from contractor sterilizers to ensure compliance with Device History Record requirements and support final release of sterile products. Analyze statistical data for sterilization and environmental parameters to assess compliance with applicable standards. Coordinate monthly environmental monitoring activities, analyze results, evaluate trends, resolve incidents, and maintain accurate monitoring records. Participate in external sterilizer or microbiology lab audits, and act as the manufacturing sterilization and environmental SME for internal or notified body audits. The Essential Requirements Of The Job Include Professional Engineering title in Chemical, Bio‑Chemical, Industrial Chemical Engineering or equivalent. 6–8 years of experience in a role such as quality engineer, sterilization or environmental engineer. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence in Spanish and English. Experience with quality assurance, 21 CFR Part 820, ISO 13485, ISO 11135, ISO 11137, ISO 11737, ISO 14644 and ISO 14698. Travel, Motor Vehicle Record & Physical/Environment Requirements: Availability to travel to the United States (Cincinnati, OH) or other Danaher operating companies as required. Work environment: controlled environmental areas and laboratories. Physical stress required: visual and manual tasks. Additional Preferred Experience: Application of advanced mathematical concepts such as statistical techniques. Supervision of other engineering or technical roles (Environmental Eng & Sterilization Eng). Planning, promoting and organizing training activities related to GMP, environmental control and sterilization matters to improve biocontamination control. #J-18808-Ljbffr