Aseptic Sterility Program Leader (GMP)

BIO-TECHNE Corp; Minnesota; On-site; USD 116,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401k & ESPP

Tuition reimbursement

Mentorship & career development

Parental leave

Job summary

Bio-Techne is seeking a Sterility Assurance Program Manager to lead the site's CCS and sterility programs within a GMP manufacturing setting. The role focuses on aseptic processing, sterilization, environmental monitoring, and cross-functional quality leadership to ensure regulatory compliance and continuous improvement.

Candidates should have a strong background in sterility assurance, validation, and regulatory standards (FDA/EMA).

Qualifications

• Bachelor's degree in a scientific/engineering field with strong sterility background.
• Experience in GMP manufacturing, sterility assurance, and regulatory standards.
• Certifications such as CPQG/CQE or similar are a plus.

Responsibilities

• Build, maintain, and improve contamination control strategy and sterility programs.
• Lead validation, aseptic governance, and monitoring of sterilization processes.
• Drive deviation investigations, CAPAs and risk management across QA, Manufacturing, Microbiology, and Engineering.
• Ensure regulatory readiness and support inspections in FDA/EMA standards.
• Train manufacturing personnel on aseptic techniques and contamination control.

Skills

Aseptic processing

Environmental monitoring

Regulatory compliance

Root cause analysis

Education

Bachelor's degree in microbiology, Biology, Biochemistry, Chemical Engineering, or related discipline

Master's or advanced degree preferred

Tools

Sterility validation

Environmental monitoring systems

Job description

Bio-Techne is seeking a Sterility Assurance Program Manager to lead the site's CCS and sterility programs within a GMP manufacturing setting. The role focuses on aseptic processing, sterilization, environmental monitoring, and cross-functional quality leadership to ensure regulatory compliance and continuous improvement.

Candidates should have a strong background in sterility assurance, validation, and regulatory standards (FDA/EMA).