Microbiologist II

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.

Microbiologist II will be involved in learningtheapplicationofmicrobiologicalconceptstothemanufacturingprocessofamedicaldevice and understanding process monitoring to maintain microbiological quality of the final device.

What You’ll Work On

Facility and routine production microbiological support :

Provide testing support including Environmental monitoring, BSC testing, water systems and compressed air testing, product bioburden, endotoxin and particulate as required

Record review of routine microbiological test result

Technical support for facility issues in the areas of, environmental monitoring and microbiological methods

Conduct investigations

Develop and execute controlled access environment, deionized water, compressed and air qualifications

Complete environmental disturbance reports; and

Complete annual controlled access environment reports

Perform quality release for sterilization loads.

Perform validation of laboratory equipment

Manage qualifications for cleanrooms an ancillary systems as required

Develop laboratory test methods and train technicians as appropriate

Technical sterilization support :

Perform annual sterilization requalification’s as required

Assess manufacturing process changes for sterilization and microbiological impact

Data analysis of sterilization processes

Writes protocols reports and executes for qualifications for sterilization and microbiological test methods

Conduct assessments and qualifications of new or modified products or components for sterilization adoption or validation

Assist in the development of sterilization cycles

Documentation and Laboratory Procedures :

Writes new or updates current microbiologically related documents

Maintains understanding of applicable standards for continued application

Accurate record keeping of lab procedures performed and their results.

Archiving of lab records

Technical Training :

Provides training to laboratory technicians or other personnel on new equipment or new test procedures, processes as required

Provides training in the areas of sterilization validation and sterilization processes

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 OR an equivalent combination of education and work experience

Masters Degree Preferred.

Minimum 5 years With a Bachelor's degree, 5 years in a medical device / pharmaceutical, or related industry, with work experience in microbiology and / or sterilization and relevant microbiology laboratory experience.

Minimum 2 years With a Master's degree, 2 years medical device / pharmaceutical or related industry, with experience in microbiology and / or sterilization and relevant microbiology laboratory experience.

Demonstrates professional skills with excellent written communication. Able to work with minimal supervision and ability to maintain regular and predictable attendance.

Demonstrated excellent troubleshooting skills in routine out of specification situations at the Microbiologist I level. 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 5-10%, including internationally (only if required)

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer :

A fast-paced work environment where your safety is our priority (Manufacturing roles only)

Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)

Training and career development , with onboarding programs for new employees and tuition assistance

Financial security through competitive compensation, incentives and retirement plans

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

Paid time off

401(k) retirement savings with a generous company match

The stability of a company with a record of strong financial performance and history of being actively involved in local communities