Contractor Conversion: Principal Scientist, Sterility Assurance

Job Summary
This individual contributor position is responsible for the comprehensive preparation, execution, documentation, and revision of commissioning, qualifications, re-qualifications, validations, re-validations, and periodic reviews. The role focuses specifically on the microbiological aspects related to process equipment, cleaning equipment, utilities, facilities, calibrations, and preventive maintenance within the Microbiology laboratory. The position will also provide essential support to resolve and document situations concerning process equipment, cleaning equipment, utilities, and facilities that may affect the approval of laboratory test releases. Additionally, this position offers technical support and assistance for any laboratory and quality control projects requiring validation services.

Equipment used in the Laboratory: steam sterilizers, Micro plate readers for bacterial Endotoxin test, pH meter, Conductivity meter, Total Organic Analyzer, Incubators, Laminar Flow Hoods, Biological Safety Cabinets, Fume Hoods, clean rooms, etc.

Responsibilities

• Responsible for reviewing LIMS workbooks and issuances of reports, as applicable.
• Responsible for the coordination and documentation of laboratory equipment preventive maintenance. Maintain time schedules for calibrations, preventive maintenances using Maximo software.
• Responsible for the coordination and documentation of the sanitization & cleaning of laboratory and laboratory equipment.
• Responsible for the coordination and documentation of laboratory equipment calibrations and non-conformance investigations.
• Perform investigations due to deviations to established specifications and schedules.
• Coordinate and execute laboratory qualifications and validation per corporate validation procedures.
• Optimization of Microbiology laboratory equipment and facilities by coordinating these activities with service providers, laboratory personnel and local facility personnel.
• Develop and conduct laboratory testing protocols and document results.
• Keep track of testing and results, establish and analyze trends, generate reports using the Microbiology Laboratory Management System.
• Establish work schedules and maintain adequate inventory to sustain the daily activities of the lab area and ensure timely release of products.
• Ensure deviations are fully investigated and documented and inform appropriate parties when standards/specifications are not met. Advise the Laboratory Manager when testing problems and/or failures occur and provide an analysis of the data with corrective action suggestions.
• Responsible for departmental activities involved in certification/validation testing and report test results.
• Perform other related duties as assigned or required

Qualifications

• BS in Microbiology, Molecular Biology, or related discipline preferred
•  4+ years of experience in Microbiology Laboratory or related field preferred
• Familiarity with ISO standards related to microbiology testing and sterilization of medical devices and healthcare products: ISO 11737-1, ISO 11737-2, ISO 11135, ISO 11137, ISO 17665, ISO 14937, ISO11133
• Familiarity with USP Chapters: 61, 62, 71, 85, 1111, 51, 60, 1223, 1227, 1113, 1115, 1116, 1117, 1231
• Project management experience is required.
• Working knowledge of Cleanroom operations
• Technical report writing ability and strong communication skills

Anticipated salary range: $70,400 - $110,550

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 8/18/26 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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