Sterility Assurance Program Manager

Bio-Techne • St. Paul, MN

6d • $78,100 - $128,500 • Onsite

About The Position

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.

Requirements

• 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 <71>, 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.
• Bachelor’s degree in biology, Microbiology, or Engineering.
• Minimum of 5 years of experience in sterility assurance, quality assurance, or a related role within a GMP manufacturing environment.
• 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.

Nice To Haves

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

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.

Benefits

• competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• 401k plans
• employee stock purchase plan (ESPP)
• Health Saving Account (HSA)
• Flexible Spending Account (FSA)
• Dependent Care FSA
• mentorship
• promotional opportunities
• training and development
• tuition reimbursement
• internship programs
• employee resource groups
• volunteer paid time off
• employee events
• charity drives
• accrued leave policy
• paid holidays
• paid time off
• paid parental leave

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level