Microbiologist II

Job description

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job Summary:
This position involves learning the application of microbiological concepts to the manufacturing process of a medical device and understanding process monitoring to maintain microbiological quality of the final device.

Job Duties:
This position may provide facility and routine production level microbiological support and/or technical sterilization and micro methods support, as determined by management.

Facility and routine production micriobological support

• Provide Facility Microbiological support including EM, BSC testing, DI systems and compressed air testing
• Record review of routine microbiological test results
• Technical support for facility issues in the areas of, environmental monitoringand microbiological methods.
• Conduct routine out of specification investigations
• Develop and execute controlled access environment, deionized water, compressed and air qualifications
• Assess manufacturing process changes for microbial impact
• Complete environmental disturbance reports
• Complete annual controlled access environment reports

Technical sterilization and microbiological laboratory methods support

• Routine release of manufactured product
• Data analysis of sterilization processes.
• Writes protocols and reports for qualifications for sterilization and microbiological test methods.
• Conduct new product assessements for sterilization adoption or validation
• Assist in the development of sterilization cycles
• Develop laboratory test methods and train techinicans as appropriate
• Works with technicians in conducting these qualifications.
• Complete LAL sampling analysis
• Develop microbioglocial specifications for incoming components

Documentation

• Ensures correct documentation linkage flow for microbiologically related documents.
• Writes new or updates current microbiologically related documents.Maintains understanding of applicable standards and applies them to qualifications and test methods.
• Writes protocols and reports for qualifications for sterilization and microbiological test methods.
• Writes appropriate validation protocols; performs or oversees validations for new technologies, equipment, and/or test methods; creates documentation for implementation.

Technical Training

• Provides training to laboratory technicians on new equipment or new test procedures.
• Provides training in the areas of sterilization validation and sterilization processes.
• 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.

Working Conditions:
Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.

Physical Demands:

Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.

Qualifications:

• Four year degree in microbiology or related science, or a four year degree and work in the field of microbiology.
• With BS/BA Degree: Minimum of 5 years in a medical device/pharmaceutical, or related industry, with work experience in microbiology and/or sterilization and relevant microbiology laboratory experience.
• With Master's Degree: Minimum of 2 years in a medical device/pharmaceutical or related industry, with experience in microbiology and/or sterilization and relevant microbiology laboratory 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.
• Person has 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.

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