Hiring: Sterility Assurance Program Manager Company: Bio-Techne Location: St Paul, MN Job Posted Time: 2026-09-10 13:49:14 Employment Type: Internship Target Skills & Keywords : Program Management, Project Management, Quality Assurance, Risk Management, Root Cause Analysis About the job Experience: •Minimum of 5 years of experience in sterility assurance, quality assurance, or a related role within a GMP manufacturing environment. Required Skills: •Own and manage the sterility assurance program, including policies, procedures, and related documentation. •Develop, implement, and maintain sterility assurance programs including sterilization validations, bioburden testing, endotoxin testing, and contamination control strategies. •Lead cross-functional teams to assess sterility risks and develop mitigation plans. •Oversee validation and monitoring of sterilization processes including aseptic processing, sterilizer cycles, and environmental controls. •Own the planning, execution, and approval of aseptic process simulations (media fills) ensuring compliance with regulatory requirements and internal standards. •Complete aseptic process validations, including protocol development, execution, data review, and final report generation. •Ensure qualification and ongoing training of manufacturing personnel in aseptic techniques, contamination control, and sterility requirements. •Prepare detailed technical reports and documentation related to sterility assurance activities for internal review and regulatory submissions. Qualifications: •Strong knowledge of aseptic processing, sterilization methods, contamination control, microbiological testing, aseptic process simulations (media fills), and process validations. •Proven experience in the qualification and training of manufacturing personnel in aseptic techniques and sterility assurance requirements. •In-depth knowledge of EU GMP Annex 1 and the ability to apply its requirements effectively in a manufacturing environment. •Operational familiarity with regulatory requirements including FDA cGMP, EMA, USP , ISO 13485, and related standards. •Proven experience in managing sterility assurance programs and leading cross-functional initiatives. •Excellent analytical, problem-solving, and project management skills. •Strong communication and interpersonal skills. •Demonstrated capacity to influence and drive changes in a complex, regulated environment. •Detail-oriented with strong documentation and record-keeping skills. •Strong knowledge of aseptic processing, sterilization methods, contamination control, microbiological testing. Compensation: •$78,100 - $128,500 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!