Sterility Assurance Program Lead (GMP)

Research & Diagnostic Systems, Inc.; Saint Paul (MN); On-site; USD 78,000 - 129,000; Full time

Benefits offered by this job

Medical benefits

401k + ESPP

Tuition reimbursement

Paid time off

Job summary

Bio-Techne seeks a Sterility Assurance Program Manager to lead the sterility program in a GMP manufacturing environment. You will oversee aseptic processing, sterilization, and contamination controls, ensuring regulatory and internal standards are met.

You will guide cross-functional teams, conduct process validations, and provide training to manufacturing personnel. The role emphasizes continuous improvement and regulatory readiness across FDA/EMA/ISO frameworks.

Qualifications

• Knowledge of aseptic processing, sterilization, and contamination control.
• Experience with aseptic process simulations (media fills).
• Proven experience with aseptic process validations and regulatory compliance (FDA cGMP, EMA, USP).
• Ability to lead cross-functional teams and manage projects in a regulated environment.
• Strong documentation and record-keeping skills.

Responsibilities

• Own and manage the sterility assurance program and related documentation.
• Develop and maintain sterility programs including sterilization validations and bioburden testing.
• Lead cross-functional teams to assess sterility risks and mitigation plans.
• Oversee validation and monitoring of sterilization processes and aseptic processing.
• Plan, execute, and approve media fills and aseptic process simulations.
• Ensure personnel training in aseptic techniques and sterility standards.
• Prepare technical reports for regulatory submissions and internal reviews.
• Support regulatory inspections and audits as SME for sterility.

Skills

Aseptic processing

Sterilization

Contamination control

Microbiological testing

Media fills

Process validations

Regulatory knowledge

FMEA

HACCP

Cross-functional leadership

Project management

Documentation

Education

Bachelor's degree in biology, microbiology, or engineering

Advanced degree preferred

Tools

eQMS

Job description

Bio-Techne seeks a Sterility Assurance Program Manager to lead the sterility program in a GMP manufacturing environment. You will oversee aseptic processing, sterilization, and contamination controls, ensuring regulatory and internal standards are met.

You will guide cross-functional teams, conduct process validations, and provide training to manufacturing personnel. The role emphasizes continuous improvement and regulatory readiness across FDA/EMA/ISO frameworks.