Sterility Assurance Specialist

Our client, a leader in healthcare innovation, is seeking a Principal Sterility Assurance Specialist to join their team. As a Principal Sterility Assurance Specialist, you will be part of the Quality Assurance department supporting global sterilization and microbiology initiatives. The ideal candidate will demonstrate strong analytical skills, meticulous attention to detail, and excellent collaboration abilities, which will align successfully in the organization.

Principal Sterility Assurance Specialist

Eagan, MN

35/hr

• Collaborate cross-functionally with R&D, regulatory affairs, quality, and manufacturing teams to ensure compliance with ISO and FDA standards for healthcare products.
• Lead and execute sterility assurance activities for both existing products and new development projects worldwide, adhering to international standards such as ISO 11135, ISO 11137, ISO 14698, ISO 11737, and ISO 14644.
• Serve as a subject matter expert in at least two sterilization modalities, providing technical guidance and leadership.
• Support ongoing manufacturing processes, including environmental monitoring and sterilization requirements, ensuring consistent product quality.
• Prepare for and support regulatory and supplier audits by providing sterility assurance expertise and documentation.

• Extensive knowledge of ISO sterilization standards, including EO (ISO 11135), Radiation (ISO 11137), and cleanroom standards (ISO 14644).
• Strong understanding of cGMP, GDP, and experience working within FDA-regulated environments.
• Excellent teamwork and communication skills, with the ability to work effectively with international teams.
• Proven technical writing skills for developing validation protocols, reports, and SOPs.
• Experience with internal and external audits by notified bodies and regulatory agencies.

• Opportunity to work at the forefront of healthcare innovation, impacting patient safety and product quality.
• Collaborate with diverse, talented professionals in a dynamic environment.
• Engage in continuous learning and professional development within a supportive organization.
• Contribute to meaningful projects that advance global health standards.
• Be part of a company committed to solving complex challenges with compassion and empathy.

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay