Aseptic Sterility Assurance Program Lead

Bio-techne; Saint Paul (MN); On-site; USD 78,000 - 129,000; Full time

Job summary

Bio-Techne in Minnesota seeks a Sterility Assurance Program Manager to lead the aseptic processing, sterilization, and contamination control program within a GMP manufacturing environment. You’ll own policies, validations, and continuous improvement initiatives to ensure product sterility and regulatory compliance.

You will collaborate with QA, Manufacturing, Microbiology and Engineering, drive CAPA and training, and support regulatory inspections.

Qualifications

• Bachelor’s degree in biology, Microbiology, or Engineering; advanced degree preferred.
• Minimum 5 years of experience in sterility assurance, QA, or related GMP manufacturing.
• Strong knowledge of EU GMP Annex 1.
• Experience with regulatory standards including FDA cGMP, EMA, USP <71>, ISO 13485.
• Experience with risk management methodologies (FMEA, HACCP).

Responsibilities

• 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.
• Prepare detailed technical reports and documentation related to sterility assurance activities for internal review and regulatory submissions.
• Support regulatory inspections and audits, acting as the subject matter expert for sterility assurance.

Skills

Aseptic processing

Sterilization methods

Contamination control

Microbiological testing

Aseptic process simulations

Process validations

Training manufacturing personnel

Regulatory compliance (FDA cGMP)

Risk assessment (FMEA/HACCP)

Cross-functional leadership

Education

Bachelor's degree in Biology, Microbiology, or Engineering

Advanced degree preferred

Tools

eQMS

Quality management systems

Job description

Bio-Techne in Minnesota seeks a Sterility Assurance Program Manager to lead the aseptic processing, sterilization, and contamination control program within a GMP manufacturing environment. You’ll own policies, validations, and continuous improvement initiatives to ensure product sterility and regulatory compliance.

You will collaborate with QA, Manufacturing, Microbiology and Engineering, drive CAPA and training, and support regulatory inspections.