Microbiologist II

Abbott•Minnetonka, MN

2d•$61,300 - $122,700

About The Position

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.

Requirements

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

Nice To Haves

Master's Degree (± 18 years) Preferred.
Experience working in a broader enterprise/cross-division business unit model preferred.

Responsibilities

Facility and routine production microbiological 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 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.
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 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
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; and creates documentation for implementation.
Technical Training: Provides training to laboratory technicians on new equipment or new test procedures and 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.