We anticipate the application window for this opening will close on - 15 Apr 2025
Position Description:
Sr. Microbiologist- Sterilization for Medtronic, Inc. located in North Haven, CT. Analyze chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program. Prepare, clean, disinfect, and/or sterilize instruments, materials, products, and/or supplies. Interpret and evaluate the analyses in terms of accuracy and precision compared against established specifications and recommend and implement corrective action where necessary. Responsible for coordinating laboratory and sterilization internal audit processes. Responsible for Industrial Ethylene Oxide (EO) Sterilization for Medical Devices and CAPA (Corrective Action Preventive Action). Navigate the complexities of various government and industry regulations include FDA 21 CFR 820, ISO 11135, ISO13485, ISO11137, ISO11737, ISO 14644 and ISO 10993-7. Coordinate Installation Qualification (IQ), Operational Qualification (OQ), Microbiological Performance Qualification (MPQ), Physical Performance Qualification (PPQ), Commissioning/Re-commissioning for EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits. Leverage Good Manufacturing Practice (GMP), Aseptic Technique, Laboratory Information Mgmt. System (LIMS), Good Laboratory Practice (GLP), and Environmental Monitoring. Responsible for various product sampling for Bioburden and Bacterial Endotoxin testing. Relocation assistance not provided. Position works a hybrid model and is required on site at North Haven, CT location 3 days/week. #LI-DNI.
Basic Qualifications:
Bachelors’ Degree or foreign equivalent in Microbiology, Biology, Chemistry or Chemical Engineering or related engineering or scientific field and four (4) years of experience as a Microbiologist, sterilization engineer or related occupation. Or alternatively, Masters’ Degree or foreign equivalent in Microbiology, Biology, Chemistry or Chemical Engineering or related engineering or scientific field and two (2) years of experience as a Microbiologist, sterilization engineer or related occupation Must possess at least two (2) years’ experience with each of the following: Laboratory and sterilization internal audit; Industrial EO Sterilization for Medical Devices and CAPA; FDA 21 CFR 820, ISO 11135, ISO 13485, ISO11137, ISO11737, ISO 14644, and ISO 10993-7; IQ/OQ/MPQ/PPQ, Commissioning/Re-commissioning for EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits; GMP, Aseptic Technique, LIMS, GLP, and Environmental Monitoring; Product sampling for Bioburden and Bacterial Endotoxin testing. Relocation assistance not provided. Position works a hybrid model and is required on site at North Haven, CT location 3 days/week.
Salary: $106,500 to $142,800 per year
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, and Simple 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), and Capital 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
Top Skills
What We Do
Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions.
Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year.
To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.
