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Senior Microbiologist Sterilization Specialist

Research & Development
19000JLH Requisition #
Careers that Change Lives:
Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. 
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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.

The Senior Microbiologist Sterilization Specialist will provide technical solutions to organization for CRHF Sterilization Services, including CEA and Microbiology Laboratory testing requirements/coordination.  

Create and maintain department Work Instructions, MFG processes, and requirements.  
Assure that products and processes are in control and in compliance with corporate, division and regulatory agency requirements by the detection, appraisal, correction and prevention of sterilization, contamination and environmental control concerns. Make independent technical and functional decisions regarding acceptance or rejection of product components, subassemblies, solutions and the suitability of processes. 

In addition, assure that all activities are in compliance with relevant FDA GMP/GLP, ISO 9001, ISO 13485, EN46001, MDD and other relevant industry standards (ISO, ASTM, etc.)

A Day in the Life:
• Work relatively independently with guidance and direction from senior members of the staff and manager.
• Assure all Quality requirements are in compliance with regulations and product specifications 
• Provide technical support to Operations, Quality, and Sterilization Services personnel
• Use Continuous Improvement methodologies to improve quality and first time yield while reducing non-value added activities and cost
• Update Sterilization Services technical procedures, MFG processes/work instructions, validation protocols/reports, CEA compliance documents 
• Apply knowledge to the optimization of the sterilization process for multiple product lines and projects 
• Provide online production support for the clean room and sterilization areas
• Provide new product development sterilization / microbiology validation support
• Perform, coordinate, execute, and summarize all areas of sterilization validation (EtO, radiation, and steam)
• Work with little guidance to design and validate sterilization cycles for new products including new sterilizer IQ/OQ/PQ reports, calibration, and production support.
• Work with little guidance to develop, implement and maintain sterilization processes, certifications and procedures for the sterilization operations within Medtronic.
• Provide project management through all stages of sterilization including product design review, test design, and certification.  Communicate and review these plans with management or project leaders.  
• Support internal and external audits
• Prepare written responses to regulatory questions 
• Review engineering change orders. 
• Resolve non conformances and implement corrective action 
• Work with Facility Maintenance and other departments for any Sterilizer, CEA, or Lab improvement/corrective activities.
• Participate or lead special projects as assigned. 
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.
• BS in Microbiology (or Biology/Chemistry) and 5+ years with medical device operations experience
• 3+ years Sterilization Validation experience (hands on validation plans, coordination, analysis, and report)
Nice to Have:
• Expertise in sterilization standards and compliance documents
• Expertise in endotoxin testing, limits, and standards compliance
• Expertise in microbiology lab testing, including bioburden and sterility testing
• Expertise in EO residual testing and requirements
• Expertise in CEA compliance and certification
• Project Management. 
• Good written and verbal communication skills.

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)

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