What are the responsibilities and job description for the Microbiologist II position at Medtronic?
A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, retore health, and extend life for millions of people worldwide. 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 the Microbiologist II role, you will play a central role as the Controlled Environmental Area (CEA) Administrator for the Rice Creek manufacturing facility, with a responsibility for managing the environmental monitoring programs for the site’s seven cleanrooms. Activities will include assessing the impact of CEA changes, trending and interpreting environmental test results and coordinating actions in response to test excursions and unplanned disruptions. You will work closely with other teams, including Manufacturing Quality, Operations, Equipment Support, Facilities and the Microbiology Lab personnel. You will also be responsible for maintaining applicable procedures and driving Corrective and Preventive Actions (CAPAs), as required in response to applicable quality system issues related to environmental monitoring. You will be a part of the local Sterility Assurance team, consisting of experts in environmental monitoring and sterilization, reporting into the Global Sterility Assurance organization.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Identifies and validates molecular targets that play a key role in a particular disease process.
- Studies origin, relationship, development, anatomy, functions, and chemical processes of living organisms; this may include studies in the growth, structure, and development of bacteria and other microorganisms.
- Conducts research to determine the effects of materials such as nutrients, drugs, serums, hormones, and other substances on tissues and vital processes of living organisms.
- Analyzes materials to determine their toxic or nontoxic properties, binding and efficacy.
- Isolates or purifies analyses, and identifies hormones, minerals, proteins, and/or cultures of microorganisms to determine their biological properties.
- Examines chemical aspects of formation of antibodies and conducts research into chemistry of cells and cell division.
- May identify and produce small quantities of new drugs, pharmaceutical compounds and/or nutrients.
- Conducts environmental risk assessments for controlled manufacturing areas, develops and maintains environmental sampling plans and monitoring programs, trends and evaluates environmental monitoring test results, initiates remedial actions in response to nonconforming test results.
- Partners with cross-departmental stakeholders in the planning of changes to cleanroom areas, coordinates environmental testing and interprets results to ensure microbiological quality of product.
- Prepares cleanroom qualification study protocols and reports. Maintains applicable departmental procedures to ensure alignment with standards, regulations and enterprise policies.
- Bachelor’s Degree with 2 years of medical device environmental monitoring experience (or an Advanced degree with 0 years of experience)
Nice to Have
- Knowledge of ISO 14644, ISO 14698 and EN 17141
- Experience with process and product change management from an FDA-regulated industry
- Understanding of product bioburden and endotoxin risk factors
- Understanding of aseptic techniques and microbiological test methods
- Knowledge of statistical methods
- Knowledge of medical device terminal sterilization methods (radiation, ethylene oxide).
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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
