Microbiologist-Steriliz I

Medtronic • Villalba, PR

8d

About The Position

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 Level 1 is responsible for supporting the sterilization processes and associated microbiological testing for medical devices in compliance with regulatory and company requirements. This entry-level position works under close supervision to perform routine laboratory analyses, environmental monitoring, and biological indicator testing, ensuring the effectiveness of sterilization cycles. The role participates in the validation and routine control of sterilization processes, assists in the investigation of non-conformances, and maintains accurate records and documentation. 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. Performing routine microbiological testing (bioburden, endotoxin, sterility) on product and process samples. Conducting environmental monitoring of controlled areas to ensure compliance with cleanroom standards. Preparing and handling biological indicators for sterilization validation and routine use. Assisting in the execution and documentation of sterilization validation studies. Supporting the investigation of sterilization and microbiological non-conformances. Maintaining laboratory records, data integrity (LIMS) Collaborating with cross-functional teams (Quality, Engineering, Production) to support continuous improvement of sterilization and microbiology practices.

Requirements

• Requires a Bachelor degree and 0 years relevant experience.

Nice To Haves

• Experience or knowledge in validation of microbiological methods.
• Basic knowledge of statistics applied to laboratory processes and results.
• Availability to work outside regular hours, including third shifts and weekends when .
• Experience in validating new products and sterilization processes.
• Ability to prepare and write technical laboratory and validation reports.
• Demonstrated ability to work effectively in a team and collaborate in multidisciplinary environments.
• Bilingual, GDP, GLP, GMP
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

• 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.
• Performing routine microbiological testing (bioburden, endotoxin, sterility) on product and process samples.
• Conducting environmental monitoring of controlled areas to ensure compliance with cleanroom standards.
• Preparing and handling biological indicators for sterilization validation and routine use.
• Assisting in the execution and documentation of sterilization validation studies.
• Supporting the investigation of sterilization and microbiological non-conformances.
• Maintaining laboratory records, data integrity (LIMS)
• Collaborating with cross-functional teams (Quality, Engineering, Production) to support continuous improvement of sterilization and microbiology practices.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level