Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Mammotome, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Mammotome, our expertise and compassion for breast care makes us the indispensable partner to physicians, clinicians and patients. Our drive for developing innovative technology is rivaled only by our compassion for the people we serve, from the clinicians and surgeons who demand consistently precise solutions, to the patients and families seeking peace of mind. When you join our company, you join in the fight against breast cancer. Working at Mammotome means you will have the opportunity to collaborate with a diverse, hardworking, high-performing team committed to improving patient outcomes. As a trusted leader in breast cancer diagnostics, we invite you to join us and support products you can feel passionate about!
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Senior Engineer, Sterilization and Environmental is responsible for plan, coordinate and direct quality assurance program designed to ensure continuous accomplishment of 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 have the opportunity to:
+ Conduct periodic and special validations of sterilization, for Radiation (Routine Dose Audits & Bioburden tests) and EtO processes at the manufacturing facility. Request samples to manufacturing, coordinate shipment of samples to sterilizer/external laboratories, coordinate processing of samples (sterilization and laboratory testing). Receive and analyze sterilization process certificates and laboratory testing and writing of internal protocols and reports and submit documents for approvals per requirements of ISO 11137 and ISO 11737.
+ Receive, review, analyze, and track sterilization results from sterilizer contractors (Gamma and EtO) to ensure all parameters met required specifications/requirements and assist to Final Release Department to release sterile products per Device History Record (DHR) requirements.
+ Review and analyze statistical data for sterilization and environmental processes specifications to determine accomplishment to applicable standards and establish proposed quality and reliability expectancy of finished product.
+ Conduct and coordinate monthly Environmental Monitoring activities, analyze routine and special monitoring results, evaluate trending and resolve incidences. Complete final reports and maintain updated Environmental Monitoring information.
+ Responsible to participate or conduct external sterilizer or microbiological labs audits, and participate in internal or notified body audits as the manufacturing sterilization and environmental SME.
The essential requirements of the job include
+ Professional Engineering title (Chemical, Bio-Chemical, Industrial Chemical Engineering or equivalent).
+ 6 – 8 years in similar 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.
+ Quality Assurance, 21 CFR Part 820, ISO 13485, ISO11135, ISO11137, ISO 11737, ISO 14644 & ISO 14698 experience.
Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role
+ Travel Requirements: Availability to travel to U.S.A (Cincinnati, OH) or another Op Cos as required
+ Work environment: Controlled Environmental Areas and Laboratories.
+ Physical stress required: Visual and manual
It would be a plus if you also possess previous experience in:
+ Ability to apply advanced mathematical concepts such as statistical techniques.
+ May supervise other engineering or technical roles such as: Environmental Eng & Sterilization Eng.
+ Plans, promotes and organizes training activities related to Good Manufacturing Practices, Environmental Control and Sterilization matters to improve Bio-contamination control.
Mammotome, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com .
