Sr Microbiologist-Sterili Supv

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

Experienced professional in sterility assurance, microbiology, and environmental control, with expertise in contamination control, sterilization validation, and cleanroom operations. Focused on compliance, product quality, and continuous improvement.

Responsibilities may include the following and other duties may be assigned.

• Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program.
• Prepares, cleans, disinfects, and/or sterilizes instruments, materials, products, and/or supplies.
• 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.
• Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
• May also be involved in establishing requirements for the transfer of methodology from R&D.
• Coordinate the sterility assurance program by leading and supporting EO cycle qualification and requalification, radiation dose audits, EO and radiation annual reviews, and other special testing activities, such as comparative resistance studies and ethylene oxide residual testing.
• Lead and support new product transfers and introductions as the sterilization and microbiology representative.
• Conduct sterilization and microbiology impact assessments for product or packaging changes.
• Coordinate and support product release activities related to sterilization.
• Coordinate the bioburden and LAL programs to ensure control, verification, and maintenance of product families.
• Develop in-house microbiology and environmental testing techniques and coordinate activities with external laboratories.·         Support environmental control activities for cleanrooms and critical facility systems.
• Maintain risk management files related to sterilization, environmental control, and microbiology.
• Generate, investigate, and follow up on nonconformances and CAPAs related to sterilization, microbiology, and environmental control.·         Maintain trend analysis for processed loads, product damage during transit or at sterilizer plants, and sterilization process failures, and prepare associated reports.
• Review and update documentation related to sterilization processes, environmental control, and microbiology.
• Support internal and external audits related to environmental control, microbiology, and sterilization.
• Support regulatory submissions related to environmental control, microbiology, and sterilization.
• Lead or participate on projects in alignment with company optimization strategies·
• Notify actions, unsafe conditions and environmental risks observations in any of the areas of the plant.
• Manage a team of technicians and/or engineers by assigning and monitoring tasks, providing ongoing coaching and feedback, and evaluating performance

• Bachelor’s Degree in Biological sciences or chemical engineering
• Experience for at least 8 years in Sterilization and Microbiology area
• Experience in Principles of Ethylene Oxide, Radiation (GAMMA, Ebeam) sterilization method.
• Experience in Microbiology Principles for Product sterility, Bioburden Testing, Bacterial Endotoxin.
• Advanced English Level
• Knowledge of international standards related to sterilization, microbiology and environmental control (ISO 11135, ISO 11137, ISO 11737, ISO 10993, AAMI TIR28, ISO 14644, ISO 14698, ISO 17025, ANSI /AMMI ST72, CFR 21 part 58 and USP chapters 1116 and 1117.
• Knowledge of Medical Device Quality system (ISO 13485)
• Knowledge of Root cause analysis (Five Whys, Fishbone Diagram (Ishikawa), FMEA) Good Manufacturing practices and good documentation practices.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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