September 21, 2020
About The Opportunity
This position is responsible to provide technical leadership in the delivery of the sterilization efforts for Cantel Medical products. This includes, supporting the team in conducting studies and performing testing. In addition, position will be responsible to support the communication and publishing of results.
- Partner with cross-functional leadership to devise and execute sterilization validations within a varying range of modalities such as steam, EO, vapor H2O2or radiation for regulatory review.
- Contribute as primary SME and technical team leader for sterilization focused projects
- Ensure all testing is conducted by approved standards and guidance\'s such as AAMI, AOAC966.04, ASTM, FDA, EPA, and ISO 14937.
- Support laboratory testing and studies including: propagation of bacterial cultures, d-value analysis, spore suspension testing, biological indicator analysis, etc as defined by management
- Analyze and summarize data for cross functional review
- Author detailed experimental protocols and reports, standard operating procedures and other controlled documents
- Develop and validate laboratory test methods
- Provide technical summaries and reviews to leadership regarding sterilization projects, new developments in industry, scientific principles, healthcare guidelines
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Oversee product evaluation studies, review data, ensure accurate incorporation of results. Ensure study timelines.
- BS in Life Sciences from four-year college or university
- Five(5) years’ experience in microbiology laboratory, medical device industry or analytical testing.
- Certified in sterilization for medical devices (AAMI, NAMSA & Nelson provide this course) or trained on a validation by a certified sterilization microbiologist
- Demonstrated knowledge of biological indicators (BIs) is required.
- Strong knowledge of bacterial endotoxin testing, bioburden testing, environmental monitoring, aseptic technique, Bacteriostasis / Fungistasis testing and biocompatibility is desired. Skill/Experience/Education
- Mandatory Experience with E-beam sterilization, medical device manufacturing, cleanrooms Required Skills
- Bacterial Endotoxic Testinge - beam sterlization Work Authorization
- US Citizen
- Green Card
Please Contact me to discuss the hiring process!
Sr. Executive Recruiter
Contact: (310) 929-8421 Ext: 104
Hi! My name is Sumit Gupta. I treat all my consultants in a manner that they feel comfortable while working with me on any position they are applying for. Although, the motive is to find the best match for my consultants. But I make sure that I suggest them the right job matching their profile and work history by interacting with them in detail and follow-up with them at each and every level of the hiring process.