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Senior Principal Sterilization Engineer

Company: Cordis
Location: Hialeah
Posted on: August 7, 2022

Job Description:

Job Description Essential Duties and Responsibilities I ncludes the following. Other duties may be assigned depending on the needs of the business. Responsible for writing, reviewing, approving sterilization technical protocols and reports, planning, and executing sterilization validations, annual reviews of sterilizers including the preparation of dunnage materials. Support dose setting, dose audits and dose mapping projects Coordinates and executing Natural Product Resistance Testing Provide sterilization technical support to project engineering teams Will serve as subject matter expert on the sterility assurance product evaluation team and provide technical input with respect to the impact product changes and sterilization deviations may have on the sterility of the product. May at times assist with coordinating the laboratory testing as required to include bioburden and sterility testing. Writes technical memos to support release of products. Must be able to solve complex problems where analysis of situations or data requires an in-depth evaluation of various factors and determine direction and adequacy of designs and test results and recommends changes. Applies engineering concepts with cycle development and product adoption. May supervise technical scientists and/or technicians on projects related to sterility assurance Practices company safety and quality policies and procedures. Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Generates change requests and works closely with cross-functional partners in coordinating sterilization assessments, waivers and design of new sterilization cycles. Provides technical support to Packaging, R&D, New Product Development with recommendations for packaging, materials and sterilization modalities Will have an active participation in industry meetings such as AAMI and ISO May present at industry meeting, forums and seminars Executes complex assignments designed to continue the development of professional work knowledge and abilities requiring enhanced application of standard engineering techniques in sterilization, procedures and criteria in carrying out sterilization tasks. May assist with regulatory audit and assist with technical audits at contract sterilizers. May assist with gap assessment for Implementation of new or revised sterilization standards EDUCATION and/or EXPERIENCE : A bachelor---s in engineering, biology, industrial microbiology, biomedical sciences, sterility assurance or science, with at least 10 years of related experience and/or training, or master---s degree and 8 or more years of experience and/or training Experience in industrial sterilization is required. Experience in microbiology will be an added asset. Candidates will have broad experience in a number of critical sterilization technologies e.g., gamma, e-beam, ethylene oxide and x-ray. Must have knowledge of process excellence, process improvement and risk analysis tools. Must be proficient in Microsoft Word, Microsoft Project, Excel, and PowerPoint and Lucid Chart. Must be experienced with developing spreadsheet models, relational databases, and presentations. Ability to effectively solve complex problems and ability to influence and communicate across all functional groups and levels is a requirement. Must be able to support multiple projects and experienced in driving results by influencing others in a highly cross-functional environment with new product development, manufacturing, quality and sourcing. Must have knowledge of GMP, QSR, ISO Standards, must have experience working with implantable medical device. This position requires domestic and international travel up to 20%. The position requires a combination of being onsite and remote. Bi-lingual is an added asset.

Keywords: Cordis, Hialeah , Senior Principal Sterilization Engineer, Engineering , Hialeah, Florida

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