Medtronic
Position Description:
Sr. Microbiologist Sterilization for Medtronic, Inc located in Danvers, MA. Responsible for products in the form of finished medical devices within the Interventional Vascular/ Cardiac Rhythm Disease Management Business supporting on-market product sterilization validations to include product sterilization validations Microbial Performance Qualification and Process Performance Qualification (MPQs/PPQs). 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 to include FDA 21 CFR 820, ISO 11135, ISO13485, ISO 11137, ISO 11737, ISO 14644, and ISO 10993‑7. Coordinate Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Commission/Re‑commission EO Sterilization Chambers, Sterilization adoptions, and Radiation Dose Audits (Gamma and Ebeam). Leverage Good Manufacturing Practices (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. Leverage compendial Association for the Advancement of Medical Instrumentation (AAMI) and United States Pharmacopeia (USP) methodologies and techniques. Leverage knowledge from being a Certified Industrial Sterilization Specialist (CISS). Relocation assistance not available for this position. Position is required to be onsite in Danvers, MA, 4 days per week, and permits remote work 1 day per week.
Basic Qualifications: Masters’ Degree or foreign equivalent in Microbiology, Biology, Chemistry, Biological Engineering, 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 (Gamma and Ebeam); GMP, Aseptic Technique, LIMS, GLP, and Environmental Monitoring; Product sampling for Bioburden and Bacterial Endotoxin testing; Compendial (AAMI & USP) methodologies and techniques. The following certification is required: Certified Industrial Sterilization Specialist (CISS)
Salary: $$119,000 to $145,200 per year
Benefits: 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
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Basic Qualifications: Masters’ Degree or foreign equivalent in Microbiology, Biology, Chemistry, Biological Engineering, 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 (Gamma and Ebeam); GMP, Aseptic Technique, LIMS, GLP, and Environmental Monitoring; Product sampling for Bioburden and Bacterial Endotoxin testing; Compendial (AAMI & USP) methodologies and techniques. The following certification is required: Certified Industrial Sterilization Specialist (CISS)
Salary: $$119,000 to $145,200 per year
Benefits: 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
#J-18808-Ljbffr