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In the Microbiologist II role, you will play a central role as the Controlled Environmental Area (CEA) Administrator for the Rice Creek manufacturing facility, with a responsibility for managing the environmental monitoring programs for the site’s seven cleanrooms. Activities will include assessing the impact of CEA changes, trending and interpreting environmental test results and coordinating actions in response to test excursions and unplanned disruptions. You will work closely with other teams, including Manufacturing Quality, Operations, Equipment Support, Facilities and the Microbiology Lab personnel. You will also be responsible for maintaining applicable procedures and driving Corrective and Preventive Actions (CAPAs), as required in response to applicable quality system issues related to environmental monitoring. You will be a part of the local Sterility Assurance team, consisting of experts in environmental monitoring and sterilization, reporting into the Global Sterility Assurance organization.A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Identifies and validates molecular targets that play a key role in a particular disease process.
• Studies origin, relationship, development, anatomy, functions, and chemical processes of living organisms; this may include studies in the growth, structure, and development of bacteria and other microorganisms.
• Conducts research to determine the effects of materials such as nutrients, drugs, serums, hormones, and other substances on tissues and vital processes of living organisms.
• Analyzes materials to determine their toxic or nontoxic properties, binding and efficacy.
• Isolates or purifies analyses, and identifies hormones, minerals, proteins, and/or cultures of microorganisms to determine their biological properties.
• Examines chemical aspects of formation of antibodies and conducts research into chemistry of cells and cell division.
• May identify and produce small quantities of new drugs, pharmaceutical compounds and/or nutrients.
• Conducts environmental risk assessments for controlled manufacturing areas, develops and maintains environmental sampling plans and monitoring programs, trends and evaluates environmental monitoring test results, initiates remedial actions in response to nonconforming test results.
• Partners with cross-departmental stakeholders in the planning of changes to cleanroom areas, coordinates environmental testing and interprets results to ensure microbiological quality of product.
• Prepares cleanroom qualification study protocols and reports. Maintains applicable departmental procedures to ensure alignment with standards, regulations and enterprise policies.