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 114,000 colleagues serve people in more than 160 countries.

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 around the world and named one of the most admired companies in the world by Fortune.

The Opportunity

his position works out of our Sylmar, CA location in the Cardiac Rhythm Management division.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Staff Microbiologist consistently applies 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

• Facility and Routine Production Microbiological Support: Develop and execute controlled access environment qualifications, specifications, and environmental disturbance reports. Develop and execute water system qualifications, compressed air systems, and specifications. Provide guidance on controlled access environment gowning requirements. 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. Independently conceives, plans, and conducts complex and/or original technical projects. •

• 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 validations for ethylene oxide and steam cycles per regulatory requirements. Perform product sterilization adoptions.

• 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 chemical sterilization and aseptic processing. Knowledge of reusable device regulatory requirements. Develop and validate microbiological test methods.

• Train laboratory technicians to microbiological test methods and equipment. Review routine microbiological test reports. Proactively identifies and shares opportunities, concerns, and solution with coworkers. Mentor microbiology technicians and provide technical expertise. Conduct calibration out of tolerance investigations.

• Responsible for the successful completion of moderate risk assignments that will have a significant impact on the department.

• 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

• Quality Assurance Support: Review and release routine product sterile loads. Review and support supplier change notifications. Develop and review FMEAs. Act as a subject matter expert for supplier audits and internal/external audits. 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. 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.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelors Degree Microbiology or related science

• Masters Degree Microbiology or related science preferred

• OR an equivalent combination of education and work experience

• Minimum 7 years Medical device/pharmaceutical, or related industry with work experience in microbiology and/or sterilization and relevant microbiology lab experience.

• Minimum 3 years With master's, experience in a medical device/pharmaceutical or related industry with work experience in microbiology and/or sterilization and relevant microbiology lab experience. 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. 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 Senior Microbiologist level or equivalent. Experience working in a broader enterprise/cross-division business unit model preferred. 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.

• Ability to travel approximately 15-25%, including internationally(only if required).

Apply Now (https://www.jobs.abbott/us/en)

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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 www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com