Sterility Assurance Specialist

Medline; United States; On-site; USD 79,000 - 116,000; Full time

Job summary

An established industry player is seeking a dedicated professional to lead sterilization activities for medical devices and pharmaceuticals. In this pivotal role, you will ensure compliance with FDA regulations and ISO standards while applying your expertise in engineering, microbiology, and chemistry. Your responsibilities will include coordinating sterilization projects, designing validation protocols, and providing technical support during audits. Join a forward-thinking company that values diversity and offers a competitive rewards package, including health insurance and 401(k) contributions. This is an exciting opportunity to make a significant impact in a growing organization.

Benefits

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Qualifications

• 2+ years experience in industrial sterilization of healthcare products.
• Strong understanding of ISO standards and microbiology principles.

Responsibilities

• Coordinate sterilization activities and maintain compliance with regulations.
• Design and execute sterilization projects and validation protocols.
• Provide technical support during audits and evaluate testing.

Skills

ISO 11135

ISO 11137

Microbiology principles

Chemistry principles

Sterilization processes

Education

Bachelor’s degree in a scientific or engineering field

Tools

Sterilization standard operating procedures

Job description

Job Summary

Prepare and execute sterilization related activities for medical device and pharmaceutical products. Support various Medline product divisions while assuring appropriate sterility assurance levels to comply with FDA regulations and ISO standards (e.g. 21 CFR Part 820/211, IS011135, ISO11137 etc.). Apply engineering, microbiology and chemistry principles to develop, support and troubleshoot sterilization processes and challenges across multiple modalities

Job Description

Responsibilities:

• Coordinate sterilization activities among Medline and contract sterilization facilities for ethylene oxide and radiation modalities in order to maintain compliance to regulations and industry standards including 21 CFR Part 820, ISO 13485, ISO 11135, and ISO 11137.
• Design and execute sterilization projects including preparation of validation protocols and reports, review and analysis of test results to ensure correct acceptance criteria and prepare a final report for approval.
• Assign sterilization cycles to new products based on the review of materials, product construction, and packaging. Review the validated process to make sure the item can be sterilized in this process.
• Review sterilization process deviations and work with division QA to determine product disposition. Provide instructions to the sterilization facility for re-processing and any additional evaluation required prior to final release.
• Provide technical support as needed during audits of Medline facilities, sterile vendors, sterilization facilities, and contract laboratories to ensure compliance with regulatory requirements.
• Evaluate, coordinate and troubleshoot testing for ethylene oxide residuals and bioburden testing at internal and external test laboratories.
• Review and revise sterilization-related procedures as needed when a new sterilization process is added or there is a change in current process.
• Train contract sterilization vendors on Medline validation requirements and procedures.
• Develop and validate new process challenge devices for ethylene oxide sterilization cycles. Work on global cycle optimization efforts.
• Prepare and modify sterilization standard operating procedures.

Qualifications:

• Bachelor’s degree with a scientific or engineering background.
• At least 2 years relevant experience in industrial sterilization of healthcare products
• Strong understanding of ISO 11135 and ISO 11137.
• Strong understanding of microbiology principles related to terminal sterilization.
• Strong understanding of chemistry principles related to EO/ECH residuals. Ability to work safely in environments where hazardous chemicals may be encountered under corporate safety rules and requirements.
• Position requires travel up to 50% of the time for business purposes (within state and out of state).

Preferred Qualifications:

• CISS (Certified Industrial Sterilization Specialist).

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$79,560.00 - $115,440.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.