Purpose
* Become an integral part of our innovative operations team at BVI®. In this key role, you will be responsible for overseeing designated site industrial sterilization, environmental, and endotoxin validation and monitoring in support of manufacturing operations and research and development. Join us in driving operational efficiency, continuous improvement, and maintaining the highest quality standards.
Key Responsibilities
* Develop and perform validations of gamma and ethylene oxide industrial sterilization, including performing quarterly gamma dose audits, bioburden monitoring, and annually reviewing the sterilization families for changes.
* Develop and perform validations of cleanrooms, controlled areas, and utilities, including performing testing for validation and ongoing monitoring, and reviewing data to identify trends.
* Responsible for monitoring, auditing, and reviewing sterilization and environmental monitoring processes and external testing laboratories, as well as associated procedures.
* Review and resolve problems identified through environmental monitoring, industrial sterilization, sterilization monitoring, and endotoxin monitoring, including the documentation of out of specification reports and corrective and preventive actions (CAPA), and communication to operations staff regarding the risks and actions for resolution.
* Review and assess changes impacting environmental monitoring and sterilization.
* Perform continuous improvement activities to maintain compliance to current standards, reduce variation in the process, and eliminate activities that do not add value using problem solving, six sigma, and lean principles.
Qualification
* Bachelor of Science in Microbiology, Biology, or other scientific discipline, plus a minimum of five years’ work experience as a sterilization engineer or industrial microbiologist, or an equivalent combination of education and experience.
* Other degree programs with microbiology, biology, science, or engineering course work may be considered if candidates also possess relevant industrial microbiology and/or sterility assurance work experience
Company
BVI® is refocusing the future of vision.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.
We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at www.bvimedical.com