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.

Job Title: Principal Sterility Assurance Specialist 

Location: Eagan, MN

Pay Range: 35/hr

What's the Job?

• 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.

What's Needed?

• 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.

What's in it for me?

• 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.

Upon completion of waiting period, consultants are eligible for:

• 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

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.