Microbiologist-Steriliz I

**Careers that Change Lives**A Day in the LifeResponsibilities may include the following and other duties may be assigned.- Work in collaboration, guidance and direction from senior members of the team and manager.- Assure all quality requirements are in compliance with regulations and product specifications.- Perform, coordinate, execute and summarize all areas of sterilization validation (EO, radiation, steam and chemical sterilization) In collaboration with a senior member of the team.- Support the execution of sterilization validation cycles for new products.- Work with guidance to maintain sterilization processes, certifications and procedures for the sterilization operations.- Support internal audits.- Review engineering change orders.- Support in the resolution of non-conformances and implement corrective action.- Work with facility maintenance and other departments for any Sterilizer and CEA improvement/corrective activities.- Participate in special tasks as assigned.- Reviews change control notifications for impact to sterilization/microbial testing.- Supports that the Microbiology / Sterilization function is maintained per industry standards.**Must Have: Minimum Requirements**- Bachelors degree in Chemistry, Biology or similar technical discipline required with 1+ years of experience.- Thorough knowledge of fundamental microbiology principles and bacterial lethality.- English Language: Advance.- Working knowledge of MS Word, Excel, PowerPoint, MS Outlook, Project.**Nice to Have**- 1+ years of experience in Ethylene Oxide Sterilization validation.- Environmental Monitoring (EM) 1+ years of experience.- Expertise in clean room requirements and gowning requirements.- Ability to multi-task, skilled in planning, organizing, coordinating projects, and working independently.- Ability to write protocols, reports, procedures, and work instructions.- Ability to read and interpret documents related to medical device sterilization and cleanrooms Including: International standards, regulations, technical procedures, journals, regulatory publications.- Expertise in cGMP's and quality systems as related to terminally sterilized medical devices.- Familiar with ISO and guidance documents related to sterility assurance - sterilization (ISO *****, ISO TIR *****, AAMI TIR 39, ISO*****, ISO*****, ISO*****), microbiology (ISO ***** series, ST72), cleanrooms (ISO ***** series, ISO *****, AAMI TIR 52), and quality systems (ISO *****).- Possess a proactive-preventative mind set and actively pursues continuous improvements.- Must be an effective team player intra-departmentally and cross functionally.- Ability to implement and defend business processes that impact sterilization.- Knowledge to execute and document investigations related to environmental and product bioburden non-conformances and sterilization equipment out of tolerance.**About Medtronic**Together, we can change healthcare worldwide.At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.We challenge ourselves and each other to make tomorrow better than yesterday.It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.Let's work together to address universal healthcare needs and improve patients' lives.Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile.The employee is also required to interact with a computer, and communicate with peers and co-workers.Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.(ADA-United States of America)