Sterility Assurance Scientist II

This position requires experience in sterility assurance with experience with different sterilization modalities such as Ethylene Oxide, Gamma, and E-Beam as well as industrial microbiology and analytical chemistry. The incumbent must have excellent communication, presentation and technical writing skills and be able to write technical protocol and reports and be proficient and knowledgeable with both the US and International sterilization, microbiology and analytical regulations and standards. ESSENTIAL DUTIES AND RESPONSIBILITIES:
Includes the following. Other duties may be assigned depending on the needs of the business.
• Responsible for writing, reviewing, approving technical protocols and reports, planning, and executing sterilization validations, annual reviews of sterilizers, support dose setting, dose audits and dose mapping projects and coordinate and executing Natural Product Resistance Testing
• Provide sterilization, microbiology, and analytical chemistry technical support to project engineering teams
• May at times perform microbiology and analytical testing.
• May serve as subject matter expert on sterility assurance product evaluation team and provide technical input with respect to the impact on product changes, sterilization nonconformances and/or lab deviations.
• May at times assist with coordinating microbiology and analytical laboratory testing.
• Develops, support and executes supplier quality agreements, supplier process specifications.
• Prepares and presents lab and sterilizer lab metrics.
• Must be able to lead technical projects
• 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.
• May 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 statistical techniques.
• May assist with regulatory audit and assist with technical audits at contract sterilizers or labs.
• May assist with gap assessment for Implementation of new or revised sterilization standards
• Responsible for communicating business related issues or opportunities to next management level
• Follow all company guidelines related to Health, Safety and Environmental practices
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
• Performs other duties assigned as needed

Requirements:

A bachelor’s in biology, industrial microbiology, chemistry, biomedical sciences, sterility assurance or science, with at least 8 years of related experience and/or training, or master’s degree and 6 or more years of experience and/or training. Experience in industrial sterilization, microbiology and analytical chemistry is required.