Sterility Assurance Program Manager

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

Job summary

Bio-Techne is seeking a Sterility Assurance Program Manager to lead the sterility program within a GMP manufacturing setting. You will own policies, validation efforts, and contamination controls to ensure product sterility while maintaining compliance with FDA/EMA/ISO standards.

You will collaborate with QA, Manufacturing, Microbiology, and Engineering to drive continuous improvement, plan media fills, and oversee aseptic processing validations, ensuring timely regulatory submissions and robust

Qualifications

• Bachelor's in biology, microbiology or engineering; advanced degree preferred.
• Minimum 5 years' experience in sterility assurance, quality assurance, or related GMP manufacturing
• Strong knowledge of aseptic processing, sterilization, contamination control, and regulatory standards

Responsibilities

• Own and manage the sterility assurance program, including policies, procedures and documentation.
• Develop and maintain sterilization validations, bioburden and 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 and aseptic processing.
• Plan, execute and approve media fills; ensure regulatory compliance and internal standards.
• Complete aseptic process validations and finalize reports.
• Ensure training of manufacturing personnel in aseptic techniques and sterility requirements.”
• Prepare technical reports for internal and regulatory use.
• Stay updated on EU GMP Annex 1 and related regulatory changes.

Skills

Sterility assurance

Regulatory knowledge

Cross-functional collaboration

Project management

Analytical thinking

Education

Bachelor's degree in biology, microbiology, or engineering

Advanced degree preferred

Tools

eQMS

Job description

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

$78,100.00 - $128,500.00

Position Summary

The Sterility Assurance Program Manager is responsible for the development, implementation, oversight, and continuous improvement of the sterility assurance program within a GMP-regulated manufacturing environment. This role ensures that all processes related to aseptic processing, sterilization, and contamination control meet regulatory requirements and internal quality standards to guarantee product sterility.

Key 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.
• Own the planning, execution, and approval of aseptic process simulations (media fills) ensuring compliance with regulatory requirements and internal standards.
• Complete aseptic process validations, including protocol development, execution, data review, and final report generation.
• Ensure qualification and ongoing training of manufacturing personnel in aseptic techniques, contamination control, and sterility requirements.
• Prepare detailed technical reports and documentation related to sterility assurance activities for internal review and regulatory submissions.
• Ensure compliance with applicable regulations and standards (e.g., FDA, EMA, USP, ISO), with specific knowledge and application of EU GMP Annex 1 guidelines.
• Collaborate with Quality Assurance, Manufacturing, Microbiology, and Engineering departments to drive continuous improvement initiatives.
• Manage deviation investigations, root cause analysis, and CAPA related to sterility assurance issues.
• Conduct training and provide guidance on sterility assurance principles and best practices.
• Support regulatory inspections and audits, acting as the subject matter expert for sterility assurance.
• Monitor sterility assurance metrics and prepare reports for senior management.
• Stay updated with advances in sterility assurance technologies, regulatory changes, and industry best practices including Annex 1 revisions.

Qualifications

• Strong knowledge of aseptic processing, sterilization methods, contamination control, microbiological testing, aseptic process simulations (media fills), and process validations.
• Proven experience in the qualification and training of manufacturing personnel in aseptic techniques and sterility assurance requirements.
• Experience owning, executing, and reporting on aseptic process validations in compliance with regulatory standards.
• In-depth knowledge of EU GMP Annex 1 and the ability to apply its requirements effectively in a manufacturing environment.
• Familiarity with regulatory requirements including FDA cGMP, EMA, USP , ISO 13485, and related standards.
• Experience with risk management methodologies and tools (e.g., FMEA, HACCP).
• Proven experience in managing sterility assurance programs and leading cross-functional initiatives.
• Excellent analytical, problem-solving, and project management skills.
• Strong communication and interpersonal skills.
• Ability to influence and drive changes in a complex, regulated environment.
• Detail-oriented with strong documentation and record-keeping skills.

Education and Experience

Bachelor's degree in biology, Microbiology, or Engineering. Advanced degree preferred.

Minimum of 5 years of experience in sterility assurance, quality assurance, or a related role within a GMP manufacturing environment.

Knowledge, Skills, and Abilities

• Strong knowledge of aseptic processing, sterilization methods, contamination control, microbiological testing.
• Experience with aseptic process simulations (media fills) including planning, execution, and approval.
• Proven experience in completing aseptic process validations and report generation.
• Ability to qualify and train manufacturing personnel in aseptic techniques and sterility assurance standards.
• Strong analytical and problem-solving skills with attention to detail.
• Good communication skills, able to clearly document and report findings.
• Effective project and time management skills.
• Ability to work collaboratively across multiple departments and influence stakeholders.

Preferred Skills

• Experience with sterile dosage forms manufacturing.
• Proficiency with electronic quality management systems (eQMS).
• Advanced degree in relevant scientific discipline.

Working Conditions

Onsite work requir