Sterility Assurance Program Manager

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Pay Range:

$ - $

The Sterility Assurance Program Manager serves as the technical subject matter expert and strategic owner of the site’s Contamination Control Strategy (CCS) and sterility assurance systems within a GMP-regulated manufacturing environment. This role will be responsible for building the sterility program for products manufactured at the facility. The candidate will be responsible for driving continuous improvement, oversight, and operational execution of aseptic processing, sterilization, and environmental monitoring programs, ensuring total compliance with evolving global regulations (including EU GMP Annex 1 and FDA requirements).

• Contamination Control and Program Strategy:

  Build, maintain, and continuously improve the sites (CCS), sterility assurance program, including policies, procedures, and related documentation.

• Validation and Aseptic Governance:

  Provide technical leadership for completion of validation and monitoring of sterilization processes, including aseptic processing, sterilizer cycles, barrier systems, bioburden/endotoxin testing strategies, and environmental controls.

  Manage aseptic process validations/simulations, including protocol development, data review, and final report generation. Ensure compliance with regulatory requirements and internal standards.

• Cross-functional Quality Leadership:

  Lead deviation investigations, root cause analyses, and CAPAs related to sterility failures or environmental monitoring excursions; drive risk management tools (FMEA, HACCP).

  Collaborate with Quality Assurance, Manufacturing, Microbiology, and Engineering departments to drive continuous improvement initiatives.

  Monitor sterility assurance metrics and prepare reports for senior management.

• Regulatory and Audit Readiness:

  Ensure compliance with applicable regulations and standards (e.g., FDA, EMA, USP, ISO), with specific knowledge and application of EU GMP Annex 1 guidelines.

  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.

• Training and Compliance:

  Ensure compliance with qualification and ongoing training of manufacturing personnel in aseptic techniques, contamination control, and sterility requirements.

  Conduct training and provide guidance on sterility assurance principles and best practices.

• Education and Experience:

  Bachelor's degree in microbiology, Biology, Biochemistry, Chemical Engineering, or a related scientific/engineering discipline. Master's or advanced degree preferred.

  Minimum of 6 to 8 years of progressive experience in sterility assurance, microbiology, or validation within a sterile pharmaceuticals or biologics GMP manufacturing environment.

  Certifications (Preferred): ASQ Certified Pharmaceutical GMP Professional (CPGP), Certified Quality Engineer (CQE), or Certified Microbiologist.

• Knowledge, Skills, and Abilities:

  Regulatory & Compliance Mastery:
  In-depth knowledge of and practical experience applying EU GMP Annex 1, FDA cGMP, USP (e.g., , ), ISO 13408, and ISO 14644 standards.

  Validation Expertise:
  Proven track record in planning, executing, and reporting on aseptic process simulations (media fills), terminal sterilization cycles, and cleanroom qualification.

  Contamination Control & Investigation:
  Strong capability in leading root cause analysis (RCA),…