We anticipate the application window for this opening will close on - 9 May 2025
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
The Microbiologist-Sterilization Manager is responsible for leading and managing day-to-day activities for the Environmental Monitoring team. This includes developing, maintaining and implementing risk-based contamination control programs for cleanrooms supporting the manufacturing of terminally sterilized medical devices in accordance with applicable international standards.
Northridge, CA (100% on-site).
Periodic travel expected, approximately 10%.
Responsibilities may include the following and other duties may be assigned.
- Developing and maintaining cleanroom risk-based contamination control programs including associted monitoring
- Perform qualifications/requalifications of cleanroom environments
- Collaborate with cross-functional teams to review new/modified manufacturing equipment and/or cleanroom environments and develop risk-based verification and validation plans as part of a larger project plan.
- Develop and monitor metrics related to areas of responsibility.
- Escalates and investigates excursions and works cross-functionally to implement corrective actions.
- 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.
- 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.
- Procure, qualify and implement laboratory equipment.
- May also be involved in establishing requirements for the transfer of methodology from R&D.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor’s Degree in microbiology, biotechnology or related technical field with 5+ years of technical working knowledge of cleanroom contamination control standards (e.g. ISO 14644, ISO 14698, EN 17141) supporting manufacturing of terminally sterilized medical devices OR
Advanced Degree with 3+ of technical working knowledge of cleanroom contamination control standards (e.g. ISO 14644, ISO 14698, EN 17141) supporting manufacturing of terminally sterilized medical devices
Nice to Have
Strong interpersonal and leadership skills.
Excellent technical writing skills with an understanding of good documentation practice
Strong understanding of clean room practices/cGMP and laboratory/GLP environments
Hands-on experience developing and maintaining risk-based cleanroom contamination control program with supporting environmental monitoring
Knowledge of facility clean utilities supporting cleanroom operations (e.g. purified water, compressed gases, HVAC) and associated qualification requirements.
Hands-on experience developing, validating and implementing microbiological methods (e.g. bioburden, bacterial endotoxin, membrane filtration) to applicable industry standards
Experience developing, qualifying and implementing cleaning methods for manufacturing process equipment
Knowledge of terminal sterilization modalities - ethylene oxide, radiation, and/or moist heat
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.
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
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.
Salary ranges for U.S (excl. PR) locations (USD):$112,000.00 - $168,000.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance,Health Savings Account,Healthcare Flexible Spending Account,Life insurance, Long-term disability leave,Dependent daycare spending account,Tuition assistance/reimbursement, andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans, 401(k) plan plus employer contribution and match,Short-term disability,Paid time off,Paid holidays,Employee Stock Purchase Plan,Employee Assistance Program,Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
