Abbott
Staff Microbiologist
Abbott, Los Angeles, California, United States, 90079
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:
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
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 around the world and named one of the most admired companies in the world by Fortune. The Opportunity This 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
position is for an experienced microbiologist that demonstrates and maintains a robust and in-depth conceptual understanding of microbiological and ethylene oxide (EO) sterilization principles for application in assessment and qualification of medical devices. This role will be responsible for assessment of new or modified products to determine impact and qualification strategies for microbiological and EO sterilization aspects. This role requires comprehensive experience in EO sterilization validation, requalification, and assessment of new or modified medical devices for adoption into an EO sterilization cycle. What You’ll Work On Routine Microbiology Lab Support: Demonstration as a subject matter expert for microbiology lab testing (e.g. bioburden, Bacterial Endotoxin, etc.). Mentor and train microbiology lab personnel on laboratory activities as needed. Review of Microbiological test reports. Validation of Microbiology Lab Testing Processes and Equipment. Conduct investigations related to testing failures, equipment excursions or other instances as needed. Routine Production Microbiology and Sterilization Support: Demonstration as a subject matter expert for Microbiological methods and EO sterilization. Complete sterilization and microbiological assessments for production changes (i.e. process changes, packaging changes, load configuration changes, design changes, etc.). Conduct routine lot release of sterilized product. Perform investigations related to sterilization issues and product impact assessments. Troubleshoot routine and validation sterilization cycle nonconformances. Review and approve nonconforming material reports. Review, assess, and support supplier change notifications. Speak as a subject matter expert for internal/external and supplier audits. Assess manufacturing process changes for microbiological and sterilization impact. Perform annual sterilization validations for ethylene oxide cycles per regulatory requirements. Conduct calibration out of tolerance investigations. Technical Sterilization Support: Independently conceives, plans, and conducts complex and/or original technical microbiological and sterilization projects. Acts as core team member for sterilization related projects and provides input and updates to management and stakeholders as required. Assessment of change for new or existing product for product sterilization adoptions and determination of testing strategy. Develop sterilization cycle parameters and conduct hands-on activities required for validation of new cycle(s) based on device/packaging design. Prepares sterilization loads, process challenge devices, monitoring devices for sterilization activities. Ability to independently solve complex problems that may arise from sterilization validation or sterilization operations. Knowledge and ability to perform mathematical sterilization calculations (i.e. lethality, D-value, etc.). Knowledge of reusable device regulatory requirements. Develop and review FMEAs. Technical support for facility issues in the areas of environmental monitoring, product testing, EO sterilization and microbiological methods. Mentor microbiology personnel and provide technical expertise in the areas of microbiology, equipment validation, EO sterilization and other areas of the department as needed. Proactively identifies and shares opportunities, concerns, and solutions with coworkers. Documentation and Technical Writing: Maintains in-depth understanding of applicable standards and applies them to qualifications, test methods, and other areas as applicable. Exhibits and maintains good technical writing skills for protocols, reports, assessments, procedures and other documentation as required. 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 * 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. 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. 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, 10 % 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)
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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
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 around the world and named one of the most admired companies in the world by Fortune. The Opportunity This 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
position is for an experienced microbiologist that demonstrates and maintains a robust and in-depth conceptual understanding of microbiological and ethylene oxide (EO) sterilization principles for application in assessment and qualification of medical devices. This role will be responsible for assessment of new or modified products to determine impact and qualification strategies for microbiological and EO sterilization aspects. This role requires comprehensive experience in EO sterilization validation, requalification, and assessment of new or modified medical devices for adoption into an EO sterilization cycle. What You’ll Work On Routine Microbiology Lab Support: Demonstration as a subject matter expert for microbiology lab testing (e.g. bioburden, Bacterial Endotoxin, etc.). Mentor and train microbiology lab personnel on laboratory activities as needed. Review of Microbiological test reports. Validation of Microbiology Lab Testing Processes and Equipment. Conduct investigations related to testing failures, equipment excursions or other instances as needed. Routine Production Microbiology and Sterilization Support: Demonstration as a subject matter expert for Microbiological methods and EO sterilization. Complete sterilization and microbiological assessments for production changes (i.e. process changes, packaging changes, load configuration changes, design changes, etc.). Conduct routine lot release of sterilized product. Perform investigations related to sterilization issues and product impact assessments. Troubleshoot routine and validation sterilization cycle nonconformances. Review and approve nonconforming material reports. Review, assess, and support supplier change notifications. Speak as a subject matter expert for internal/external and supplier audits. Assess manufacturing process changes for microbiological and sterilization impact. Perform annual sterilization validations for ethylene oxide cycles per regulatory requirements. Conduct calibration out of tolerance investigations. Technical Sterilization Support: Independently conceives, plans, and conducts complex and/or original technical microbiological and sterilization projects. Acts as core team member for sterilization related projects and provides input and updates to management and stakeholders as required. Assessment of change for new or existing product for product sterilization adoptions and determination of testing strategy. Develop sterilization cycle parameters and conduct hands-on activities required for validation of new cycle(s) based on device/packaging design. Prepares sterilization loads, process challenge devices, monitoring devices for sterilization activities. Ability to independently solve complex problems that may arise from sterilization validation or sterilization operations. Knowledge and ability to perform mathematical sterilization calculations (i.e. lethality, D-value, etc.). Knowledge of reusable device regulatory requirements. Develop and review FMEAs. Technical support for facility issues in the areas of environmental monitoring, product testing, EO sterilization and microbiological methods. Mentor microbiology personnel and provide technical expertise in the areas of microbiology, equipment validation, EO sterilization and other areas of the department as needed. Proactively identifies and shares opportunities, concerns, and solutions with coworkers. Documentation and Technical Writing: Maintains in-depth understanding of applicable standards and applies them to qualifications, test methods, and other areas as applicable. Exhibits and maintains good technical writing skills for protocols, reports, assessments, procedures and other documentation as required. 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 * 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. 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. 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, 10 % 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)
#J-18808-Ljbffr