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Abbott · 16 hours ago

Microbiologist II

Minnetonka, MN

Full-time

Onsite

Mid, Senior Level

$61K/yr - $123K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The role of Microbiologist II involves applying microbiological concepts to the manufacturing process of medical devices and ensuring microbiological quality through various testing and documentation processes.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

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 monitoring and 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

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 assessments for sterilization adoption or validation

Assist in the development of sterilization cycles

Develop laboratory test methods and train technicians as appropriate

Works with technicians in conducting these qualifications

Complete LAL sampling analysis

Develop microbiological specifications for incoming components

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; and creates documentation for implementation

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

Support all Company initiatives as identified by management and in support of Quality Management

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

Qualification

MicrobiologySterilization methodsEnvironmental monitoringData analysisTechnical writingTroubleshooting skillsTeam collaborationCommunication skillsOrganizational skills

Required

Bachelor's Degree (± 16 years) in Microbiology or related science (OR) an equivalent combination of education and work 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

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

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

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