Microbiologist II

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: MAIN PURPOSE OF THE ROLE: 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. MAIN 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; and 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; and 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. The role is performed in an office setting and will not be performed in a laboratory setting. Education Bachelor's Degree (± 16 years) in Microbiology or related science (OR) an equivalent combination of education and work experience Master's Degree (± 18 years) Preferred. Experience/Background 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. 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 The base pay for this position is $61,300.00 $122,700.00 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 > Minnesota > Minnetonka : 14900 Minnetonka Industrial Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % 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), Work in a clean room environment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter