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.

     

JOB DESCRIPTION:

The Opportunity

This position works out of our Sylmar, CA location in the Cardiac Rhythm Management Division.

This position is for the Senior Microbiologist that 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.). Perform routine gamma dose audits. 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.

Required Qualifications

• Bachelors Degree in Microbiology or related science ☒ an equivalent combination of education and work experience
• Minimum 7 years Medical device/pharmaceutical, or related industry with work experience in microbiology

Preferred Qualifications

• Masters Degree (± 18 years) Microbiology or related science
• Or 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.
• Ability to travel approximately 15-25%, including internationally.

Apply Now

* 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

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.

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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.

JOB FAMILY:

Medical & Scientific Affairs

     

DIVISION:

CRM Cardiac Rhythm Management

        

LOCATION:

United States > Sylmar : 15900 Valley View Court

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 20 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

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: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf ID:uDnQdo