Sterility Assurance Program Manager

Bio-Techne · St. Paul, MN

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OtherFull-time$78k–$129kCompany career page

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What they're looking for

Bachelor's degree in biology, microbiology, or engineering
Minimum 5 years sterility assurance or quality assurance experience in GMP manufacturing
In-depth knowledge of EU GMP Annex 1 and FDA cGMP regulations
Proven experience planning and executing aseptic process validations and media fills
Knowledge of sterilization methods, bioburden testing, endotoxin testing, and contamination control
Experience with risk management methodologies such as FMEA or HACCP
Strong analytical, problem-solving, and project management capabilities

What you'll be doing

Develop, implement, and oversee sterility assurance policies, procedures, and documentation
Lead validation and monitoring of sterilization processes, aseptic processing, and environmental controls
Plan, execute, and approve aseptic process simulations ensuring regulatory compliance
Manage deviation investigations, root cause analysis, and corrective action plans related to sterility
Support regulatory inspections and audits as subject matter expert; stay current on industry advances

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