Pay Range:

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 <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.

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 required in GMP manufacturing environments, laboratories, and controlled production areas.

• Exposure to biologics, chemicals, and standard bioprocessing equipment.

• Work may require standing, walking, or operating equipment for extended periods.

• May require occasional early hours or weekends based on production schedules.

Physical Requirements:

• Ability to lift and move items up to 40–50 lbs.

• Ability to wear PPE required for clean room operations.

• Ability to maneuver equipment such as carts, cylinders, or supplies as needed.

• Extended periods of standing, walking, or working at production equipment and clean room environment.

• Extended periods sitting and performing computer work.