Senior Microbiologist

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have accessto: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Plymouth, MN location in the EP divison. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Microbiologist, you'll have the opportunity to apply microbiological concepts to the manufacturing process of a medical device and understands and develops process monitoring/metrics to maintain microbiological quality of the final device. What You'll Work On Validate sterilization of medical devices using a variety of sterilization modalities (ex. ethylene oxide, radiation). Write protocols/reports to conduct comparative resistance studies to determine a device's resistance to sterilization. Write protocols/reports to conduct EO/ECH residual testing. Write protocols/reports to adopt devices into validated sterilization cycles. Write protocols/reports to conduct dose establishment studies for radiation sterilization. Write protocols/reports to conduct routine dose audits for radiation sterilization. Write protocols/reports to conduct baseline bioburden and bacterial endotoxin testing. Managing logistics and scheduling of the aforementioned studies (ex. communicating sample requirements, obtaining samples, shipping to external vendors, as applicable). Facility and Routine Production Microbiological Support: Develop and execute controlled access environment qualifications, specifications, and environmental disturbance reports. Provide guidance on controlled access environment gowning requirements. Develop and execute water system qualifications, compressed air systems, and specifications. Provide guidance on cleaning processes and chemical usage. Technical support for facility issues in the areas of environmental monitoring and microbiological methods. Assess manufacturing process changes for microbial impact. Technical Sterilization and Microbiological Laboratory Methods Support: Develop sterilization parameters based on device / packaging design. Troubleshoot routine and validation sterilization cycle nonconformances. Perform annual sterilization requalification's for ethylene oxide cycles per regulatory requirements. Knowledge and ability to perform mathematical sterilization calculations (i.e. lethality, D-value, etc.). Complete sterilization assessments for production changes (i.e. process changes, packaging changes, load configuration changes, design changes, etc.). Knowledge of reusable device regulatory requirements. Develop and validate microbiological test methods. Proactively identifies and shares opportunities, concerns, and solutions with cross functional partners. Mentor microbiology technicians/microbiologists and provide technical expertise. Conduct calibration out of tolerance investigations. Documentation and Technical Writing: Maintains understanding of applicable standards and applies them to qualifications and test methods. Writes protocol and reports for qualification of the following: Controlled access environments, compressed air systems, and water systems, Microbiological test methods, Sterilization validations / product adoptions, Equipment qualifications, LAL Sampling Analysis. Writes the following technical documentation: Laboratory procedures, Procedures for routine product monitoring and incoming component specifications. Review and support supplier change notifications. Develop and review FMEAs. Review and approve nonconforming material reports. Other Requirements: Other Projects as Directed by Department Manager. Member of R&D project teams, Operations project teams, or supports other projects as directed by department manager. Member of R&D project teams, Operations project teams, or supports other projects as directed by department manager. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Required Qualifications Bachelors Degree in Microbiology or related science and/or an equivalent combination of education and work experience. Minimum 7 years experience in medical device/pharmaceutical, or related industry with work experience in microbiology and/or sterilization and relevant microbiology lab experience. Articulates technical concepts well. Person in this position has demonstrated troubleshooting skills in complex situations outside of routine out of specification issues, such as sterilization or contamination issues while at the Microbiologist II level or equivalent. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Person in this position demonstrates professional skills with excellent written communication. Able to work with minimal supervision and ability to maintain regular and predictable attendance. Ability to travel approximately 5%, including internationally. Preferred Qualifications Masters Degree in Medical device/pharmaceutical, or related industry with work experience in microbiology and/or sterilization and relevant microbiology lab experience. Minimum 3 years experience with Masters and medical device/pharmaceutical, or related industry with work experience in microbiology and/or sterilization and relevant microbiology lab experience and/or an equivalent combination of education and work experience. Experience working in a broader enterprise/cross-division business unit model preferred. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at on Facebook at and on Twitter @AbbottNews. The base pay for this position is $78,000.00 - $156,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Medical & Scientific Affairs DIVISION: EP Electrophysiology LOCATION: United States > Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol: