Microbiologist II
Location: United States – Minnesota – Minnetonka
Category: Medical and Clinical Affairs
Company: Abbott
Employment Type: Full-Time
Experience Required: 2–5+ years (depending on education level)
Travel Requirement: Approximately 5–10% (including international travel)
Compensation: USD $61,300 – $122,700 per year (may vary by location)
Job Overview
Abbott, a global leader in healthcare innovation, is seeking a Microbiologist II to support microbiological quality processes within medical device manufacturing operations. This role focuses on applying microbiological principles to manufacturing environments, ensuring process monitoring, sterilization validation, and environmental control measures to maintain product safety and compliance with regulatory standards.
The position plays a critical role in supporting microbiological quality assurance, process validation, and documentation management aligned with industry regulations and quality management systems.
Key Responsibilities
Facility and Production Microbiological Support
Provide microbiological support for manufacturing facilities, including environmental monitoring (EM), biological safety cabinet testing, deionized water systems, and compressed air testing. Review routine microbiological test results, investigate out-of-specification findings, and support facility-related microbiological issues. Execute controlled access environment qualifications, evaluate manufacturing process changes for microbial impact, and generate environmental disturbance and annual reports.
Sterilization and Laboratory Methods Support
Perform routine product release activities and analyze sterilization processes. Develop protocols and reports for sterilization validation and microbiological testing methods. Support new product sterilization validation and cycle development, perform Limulus Amebocyte Lysate (LAL) sampling analysis, and establish microbiological specifications for incoming components. Train laboratory personnel on test procedures and equipment usage.
Documentation and Compliance
Maintain and update microbiological documentation in compliance with quality management standards. Ensure proper documentation flow, develop validation protocols, and oversee qualification activities for new technologies, equipment, and testing methods. Maintain knowledge of applicable industry standards and ensure regulatory compliance, including adherence to U.S. Food and Drug Administration requirements.
Technical Training and Cross-Functional Support
Provide technical training on sterilization processes and laboratory procedures. Collaborate with cross-functional teams, support organizational quality initiatives, and contribute to continuous improvement projects within Quality Management Systems and Environmental Management Systems.
Educational Qualifications
Bachelor’s degree in Microbiology or a related scientific discipline, or an equivalent combination of education and experience.
Master’s degree in Microbiology or related field preferred.
Experience Requirements
Candidates with a Master’s degree must have a minimum of 2 years of experience in the medical device, pharmaceutical, or related industry with relevant microbiology or sterilization experience.
Candidates with a Bachelor’s degree must have a minimum of 5 years of industry experience in microbiology, sterilization processes, or related laboratory work.
Required Skills and Competencies
Strong knowledge of microbiological methods, sterilization processes, and environmental monitoring practices.
Proven experience in investigating out-of-specification results and troubleshooting microbiological issues.
Excellent written and verbal communication skills with strong documentation capabilities.
Ability to work independently with minimal supervision and collaborate within cross-functional teams.
Strong organizational, analytical, and problem-solving skills with attention to detail.
Ability to manage multiple priorities and meet deadlines in a dynamic work environment.
Work Environment
This position is primarily performed in an office-based setting and focuses on process monitoring, documentation, and quality system support rather than routine laboratory operations.
About the Company
Abbott is a global healthcare organization committed to advancing medical innovation across diagnostics, medical devices, nutrition, and branded generic medicines. With operations in more than 160 countries, Abbott focuses on improving patient outcomes and advancing healthcare standards worldwide.
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Frank Scottile Blvd |Missouri :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Tallinn |Hà Nội :
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