Senior Cleaning Validation Specialist

Careers that Change Lives

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

In this exciting role as a Senior Cleaning Validation Specialist , you will have responsibility for leading the cleaning validation program of manufacturing equipment/processes supporting commercial and new product development for the Diabetes business.

You will have responsibility to develop, validate and implement cleaning methods for a variety of manufacturing equipment to ensure product cleanliness. You will be required update to routine cleaning validation procedures and related specifications as well as support and lead assessments of new products or changes to existing products.

This position will be responsible for ensuring Diabetic patients around the world are receiving a lifesaving medical device safely free of any bioburden or contamination risk.

This position is in Northridge, CA.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life

In general, the following responsibilities apply for the Senior Cleaning Validation Specialist role. This includes, but is not limited to the following:

• The Cleaning Validation Specialist will coordinate and execute all cleaning validation activities for semi-automated manufacturing process equipment in an ISO Class 7 cleanroom
  • Provide guidance on Equipment Bioburden Acceptance Criteria/Monitoring Requirements/Alert/Action Limits
• Provide input to new product development teams developing next generation medical devices on requirements and equipment design for cleanability of equipment during development
• Responsible for leading and taking the initiative to plan and execute onsite cleaning validation programs
• Perform risk assessment and analysis for site cleaning programs to ensure regulatory agency compliance
• Partner with Microbiology Techs to conduct cleaning studies, cleaning verification swabbing, and risk sampling
• Collaborate with Operations Excellence team to leads continuous improvement activities related to cleaning and changeover optimization generating cost savings

MUST HAVE - MINIMUM REQUIREMENTS:

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

• Bachelor's degree in science or a technical discipline
• Minimum of 4 years of work experience in microbiology and sterilization experience OR Advanced degree in science or technical discipline with 2+ years of work experience in microbiology and sterilization.

Nice to Have

• Four years of experience in a Validation or Quality Assurance role for medical device or pharmaceutical environment
• 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 cleaning validations Including: International standards, regulations, technical procedures, journals, regulatory publications. Familiarity with applicable regulatory requirements.
• Working knowledge of MS Word, Excel, PowerPoint, MS Outlook, Project
• Knowledge in compendial (USP, ISO) analytical methods and techniques pertaining to area of expertise.
  

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)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.

Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience .