Senior Principal Scientist Sterility Assurance

What Sterility Assurance contributes to Cardinal Health

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Sterility Assurance performs technical studies and specialized laboratory testing to ensure that the risk of microbial contamination in our medical device product is controlled and appropriately low in our sterile product. This job family develops and executes precise monitoring and testing procedures to report on quality and regulatory science-based results in accordance with internal and external requirements. 

Responsibilities

• Demonstrates advanced understanding of quality philosophies, principles, systems, methods, tools, and standards.

• Develops, implements, and helps drive quality programs, including tracking, analyzing, reporting and problem solving.

• Responsible for project management, coordination of activities, and advanced SME technical support associated with controlled manufacturing, sterilization process R&D, development, optimization, and validation, as assigned.

• Perform sterilization process development, chamber qualification/validation, equivalency, parametric release statistical evaluations/process maintenance and implementation activities across contract sterilizers according to ANSI/AAMI/ISO requirements. 

• Perform Advanced Technical Writing including authoring of study protocols/final reports and data analysis/ verification.

• Responsible for project management, SME support, and coordination of activities associated with special projects (complaint investigation, regulatory compliance, cost savings, manufacturing operations, transformation/changes, etc.), and cross functional teams as assigned.

• Responsible for the supplier management of contract sterilizers and sterility testing support laboratories. 

• Responsible for advanced sterilization related nonconformance, deviation, and CAPA investigations.  Perform SME technical evaluations of abnormalities in sterilization processing and batch records for product release and lead special studies in support of product release.

• Authoring and maintenance of procedure, policy, and form updates within quality system.  Evaluation of procedures for compliance and alignment to industry standards, performance of gap assessments, and driving of mitigation solutions and best practices.

• Support and management of Sterility Assurance programs such as Environmental Monitoring, Bioburden Monitoring, Product Adoption, and Sterilization Metrics, as assigned.

• Provides Sterility Assurance SME support to medical device manufacturing sites, sterilization sites, laboratories, procurement, and cross functional departments and teams.

• Support and perform supplier audits including contract sterilizers, manufacturers, and microbiological and analytical laboratories.

• Support regulatory compliance audits as SME. 

• Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.

• Plans, controls, and assures product and process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems.

• Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.

• Applies problem solving and quality improvement tools and techniques, including preventive and corrective actions and how to overcome barriers to quality improvements.

• Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.

• Trains, mentors, and develops less experienced colleagues within Sterility Assurance

Qualifications

• Bachelor’s degree in microbiology, biology, chemistry, biochemistry, physics, or engineering preferred, or other related scientific field or relevant work experience, preferred

• 6+ years professional experience within an FDA regulated industry, preferably medical devices preferred

• 4+ years working experience in a quality or regulatory role preferred

• 6+ years working experience in a sterilization or sterility assurance engineering related role preferred

• Microbiology lab background experience is preferred but not required.

• Proficiency in MS Office applications and with strong project management and communication skills including scientific technical writing, preferred.

• ISO 11135 (Ethylene Oxide) and ISO 11137 and 13004 (Radiation) experience preferred

What is expected of you and others at this level

• Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects

• Participates in the development of policies and procedures to achieve specific goals

• Recommends new practices, processes, metrics, or models

• Works on or may lead complex projects of large scope

• Projects may have significant and long-term impact

• Provides solutions which may set precedent

• Independently determines method for completion of new projects

• Receives guidance on overall project objectives

• Acts as a mentor to less experienced colleagues

Anticipated salary range: $105,100 - $150,100

Bonus eligible: Yes

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: 10/10/2025 *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.

#LI-MP1

#LI-remote

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.

To read and review this privacy notice click here