A Day in the Life
Support Operational activities related to Microbiology, Laboratory and sterilization activities

The Senior Sterilization Microbiologist is responsible for leading the development, validation, and ongoing control of sterilization processes (e.g., EO, steam, radiation) to ensure product safety, regulatory compliance, and process robustness. This role provides technical expertise and strategic direction for microbiological aspects of sterilization across manufacturing and quality systems.

Key Responsibilities

• Lead sterilization validation activities (IQ/OQ/PQ, MPQ/PPQ) for new and existing products.
• Develop and review sterilization protocols, reports, and cycle parameters.
• Serve as SME for sterilization processes (EO, Gamma, E-beam, Steam).
• Ensure compliance with regulatory standards (FDA, ISO 11135, ISO 11137, ISO 17665).
• Support investigations related to bioburden, sterility failures, and deviations.
• Oversee bioburden, endotoxin, and environmental monitoring programs.
• Collaborate with cross-functional teams (Quality, Engineering, Operations, external suppliers like sterilization vendors).
• Review and approve changes impacting sterilization processes.
• Provide guidance during audits and regulatory inspections.
• Drive continuous improvement initiatives in sterilization and microbiology processes.

Qualifications- Nice to Have- Required

• Bachelor's or Master's degree in Microbiology, Biology, or related field.
• 5-10+ years of experience in sterilization microbiology (medical devices/pharma preferred).
• Strong knowledge of sterilization validation and microbiological methods.
• Experience with regulatory submissions and audits.

Key Skills

• Deep expertise in sterilization technologies and microbiology
• Strong analytical and problem-solving skills
• Leadership and project management capability
• Excellent technical writing and communication skills
• Ability to work cross-functionally and with external partners

Typical Work Environment

• Manufacturing plants, laboratories, and collaboration with external sterilization providers.
• Involvement in validation runs, audits, and technical reviews
• 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.

Must Have: Minimum Requirements:

Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. A7 214.2(h)(4)(iii)(A) is required.

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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Join us in our mission to alleviate pain, restore health, and extend life-where your unique background and perspective are valued.
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.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Medtronic benefits and compensation plans