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Sterility Assurance Lead — Aseptic Process & Compliance

Job in Saint Paul, Ramsey County, Minnesota, 55199, USA
Listing for: biotechne
Full Time position
Listed on 2026-08-22
Job specializations:
  • Business
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 78000 - 129000 USD Yearly USD 78000.00 129000.00 YEAR
Job Description & How to Apply Below

Bio-Techne is seeking a Sterility Assurance Program Manager to lead the sterility program within a GMP manufacturing setting. You will own policies, validation efforts, and contamination controls to ensure product sterility while maintaining compliance with FDA/EMA/ISO standards.

You will collaborate with QA, Manufacturing, Microbiology, and Engineering to drive continuous improvement, plan media fills, and oversee aseptic processing validations, ensuring timely regulatory submissions and robust

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