Sterility Assurance Program Manager
Bio-Techne
August 18, 2026
On-site
St Paul, MN
Operations
Position Summary
The Sterility Assurance Program Manager develops, implements, oversees, and continuously improves the sterility assurance program in a GMP-regulated manufacturing environment to ensure product sterility.
Key Responsibilities
- Own and manage sterility assurance policies, procedures, and documentation.
- Develop/maintain programs covering sterilization validations, bioburden testing, endotoxin testing, and contamination control.
- Lead cross-functional sterility risk assessments and mitigation plans.
- Oversee sterilization/aseptic process validation and environmental controls.
- Plan, execute, and approve aseptic process simulations (media fills).
- Complete aseptic process validations (protocols, execution, data review, reports).
- Qualify and train manufacturing personnel in aseptic technique, contamination control, and sterility requirements.
- Produce technical reports for internal review and regulatory submissions.
- Ensure compliance with applicable regulations/standards (FDA/EMA/USP/ISO; EU GMP Annex 1).
- Lead deviation investigations, root cause analysis, and CAPA.
- Support regulatory inspections/audits as SME; monitor and report sterility metrics.
Qualifications
- Strong knowledge of aseptic processing, sterilization, contamination control, microbiological testing, media fills, and process validations.
- Experience qualifying/training manufacturing personnel.
- Experience owning/executing/reporting aseptic process validations.
- In-depth knowledge of EU GMP Annex 1; familiarity with FDA cGMP, EMA, USP, ISO 13485.
- Risk management experience (e.g., FMEA, HACCP).
- Analytical, problem-solving, project management, and documentation skills.
Education/Experience
- Bachelor’s in Biology, Microbiology, or Engineering (advanced degree preferred).
- 5+ years in sterility assurance/quality assurance in GMP manufacturing.
Preferred Skills
- Sterile dosage form manufacturing; eQMS proficiency; advanced degree.
Application Instructions (if needed)
- For reasonable accommodation during the application process: hr@bio-techne.com.
The Sterility Assurance Program Manager develops, implements, oversees, and continuously improves the sterility assurance program in a GMP-regulated manufacturing environment to ensure product sterility.
Key Responsibilities
- Own and manage sterility assurance policies, procedures, and documentation.
- Develop/maintain programs covering sterilization validations, bioburden testing, endotoxin testing, and contamination control.
- Lead cross-functional sterility risk assessments and mitigation plans.
- Oversee sterilization/aseptic process validation and environmental controls.
- Plan, execute, and approve aseptic process simulations (media fills).
- Complete aseptic process validations (protocols, execution, data review, reports).
- Qualify and train manufacturing personnel in aseptic technique, contamination control, and sterility requirements.
- Produce technical reports for internal review and regulatory submissions.
- Ensure compliance with applicable regulations/standards (FDA/EMA/USP/ISO; EU GMP Annex 1).
- Lead deviation investigations, root cause analysis, and CAPA.
- Support regulatory inspections/audits as SME; monitor and report sterility metrics.
Qualifications
- Strong knowledge of aseptic processing, sterilization, contamination control, microbiological testing, media fills, and process validations.
- Experience qualifying/training manufacturing personnel.
- Experience owning/executing/reporting aseptic process validations.
- In-depth knowledge of EU GMP Annex 1; familiarity with FDA cGMP, EMA, USP, ISO 13485.
- Risk management experience (e.g., FMEA, HACCP).
- Analytical, problem-solving, project management, and documentation skills.
Education/Experience
- Bachelor’s in Biology, Microbiology, or Engineering (advanced degree preferred).
- 5+ years in sterility assurance/quality assurance in GMP manufacturing.
Preferred Skills
- Sterile dosage form manufacturing; eQMS proficiency; advanced degree.
Application Instructions (if needed)
- For reasonable accommodation during the application process: hr@bio-techne.com.