Principal Microbiologist-Sterilization
In this exciting role as a Principal Microbiologist – Sterilization you will support Sustaining On Market Products Sterilization Validation. You will have responsibility for all sustaining sterilization work. Sustaining work includes maintenance of validations for all on market products. Support of changes to existing products and introduction of new products.(Radiation sterilization dose audits, Ethylene Oxide sterilization validations, Bioburden Trending). These validations include product sterilization validations, along with product and process validations. The position provides technical solution to achieve validated sterilization processes for new and existing products. Updates to routine sterilization procedures and related specifications. Supports team with assessments of new products or changes to existing products. Support team with sterilization validation activities related to changes to new cleanrooms and capacity expansion projects.
DIABETES
Transforming diabetes care together, for greater freedom and better health.
Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.
A Day in the Life
- Develop sterilization validation protocols, manage work, document results in reports for electron beam radiation and ethylene oxide sterilization methods
- Develop and maintain standard operating procedures or work instructions supporting sterilization methods
- Follows protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments.
- Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
- Develops, validates, and implements controlled environment methods.
- Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.
- Participates in the preparation of investigations, summaries, and non-conformance reports and initiates protocols and final reports
- May also be involved in establishing requirements for the transfer of methodology from R&D.
- Responsible for accuracy and integrity of documentation generated, as well as compliance with cGMP’s and Quality Control guidelines issued by FDA and other applicable agencies.
- Other duties as assigned
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor of Science degree in Microbiology, Biochemistry, Biomedical Engineering or related degree with 7+ years of sterilization experience or Advanced Sciences degree in Microbiology, Biochemistry, Biomedical Engineering or related degree with 5+ years of sterilization experience.
Nice to Have
-Certified Industrial Sterilization Specialist (CISS).- 5+ years applied experience in radiation sterilization (preferably electron beam) and ethylene oxide sterilization, Device and/or Pharmaceutical QA/QC/Validation experience
- Thorough knowledge of fundamental microbiology principles, methods and procedures, including knowledge of bacteria morphology and staining, aseptic technique specifically as they relate to sterilization methods.
- Environmental Monitoring (EM) subject matter expertise.
- 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. Familiarity with FDA regulations.
- Working knowledge of MS Word, Excel, PowerPoint, MS Outlook, Project
- Expertise in cGMP’s and quality systems as related to aseptically manufactured and terminally sterilized medical devices.
- Knowledge in compendial (AAMI, USP, ISO) methodologies and techniques. ~
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 Requirements
The 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)
