Sterilization Specialist

About the role

We are seeking an experienced Sterility Assurance and Contamination Control leader to establish and enhance microbiological control strategies across a growing GMP manufacturing organization. This role will serve as the site subject matter expert (SME) for sterility assurance, contamination control, aseptic processing, and microbiological quality systems, supporting both clinical and commercial manufacturing operations. The successful candidate will have extensive experience in sterile manufacturing environments, contamination control strategy (CCS) development, aseptic process simulation programs, environmental monitoring, and regulatory inspection readiness. This individual will play a critical role in ensuring compliance with EU GMP Annex 1, FDA Aseptic Processing Guidance, USP requirements, and global regulatory expectations, while supporting commercial launch readiness and manufacturing scale‑up activities.

Key Responsibilities

• Develop, author, and continuously improve site‑wide Contamination Control Strategies (CCS) aligned with EU GMP Annex 1 and FDA aseptic processing guidance.
• Perform contamination risk assessments and drive associated remediation and continuous improvement initiatives.
• Establish and maintain inspection‑ready sterility assurance programs across manufacturing operations.
• Serve as the site SME for microbiological control, aseptic processing, and contamination prevention strategies.
• Partner with Manufacturing, Quality, Regulatory Affairs, Validation, and Technical Operations to ensure a robust contamination control framework.
• Design, execute, and maintain media fill and aseptic process simulation programs.
• Lead smoke studies and airflow visualization assessments to support facility and process qualification.
• Develop strategies for sterilizing‑grade filtration qualification, validation, and integrity testing.
• Oversee sterilization, depyrogenation, and aseptic process validation activities.
• Support process performance qualification (PPQ) and commercial manufacturing readiness efforts.
• Develop and optimize environmental monitoring programs for classified manufacturing environments.
• Establish viable and non‑viable monitoring strategies and trending programs.
• Lead microbial identification, data analysis, and contamination investigation activities.
• Perform trend analysis to identify emerging risks and drive preventive actions.
• Oversee microbiological control strategies for incoming materials, in‑process testing, and final product release.
• Support implementation, validation, and lifecycle management of rapid microbiological methods.
• Oversee endotoxin, sterility, bioburden, and mycoplasma testing strategies.
• Evaluate new technologies and testing platforms to improve efficiency while maintaining compliance.
• Ensure testing programs are scientifically justified and aligned with regulatory expectations.
• Support cleaning validation strategies for GMP manufacturing facilities and equipment.
• Develop and improve disinfectant qualification and effectiveness programs.
• Author and review CMC sections supporting aseptic processing, microbiological controls, and sterility assurance programs.
• Lead pre‑approval inspection (PAI) readiness activities.
• Serve as the primary sterility assurance SME during health authority inspections and customer audits.
• Support regulatory submissions, responses to agency questions, and ongoing compliance initiatives.
• Drive continuous improvement efforts to strengthen quality systems and inspection preparedness.

Required Qualifications

• Bachelor’s degree in Microbiology, Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related life‑science discipline.
• 10+ years of experience in sterility assurance, microbiology, aseptic processing, or sterile pharmaceutical manufacturing.
• Demonstrated experience supporting biologics, cell therapy, gene therapy, or other sterile manufacturing operations.
• Extensive knowledge of contamination control strategies and microbiological quality systems.
• Hands‑on experience leading media fill programs and aseptic process simulations.
• Strong understanding of EU GMP Annex 1 (2022), FDA Aseptic Processing Guidance, USP standards, and global GMP regulations.
• Experience leading contamination investigations, root cause analysis, and remediation efforts.
• Proven ability to work cross‑functionally in a dynamic, regulated manufacturing environment.

Preferred Qualifications

• Experience supporting autologous cell therapy manufacturing operations.
• Experience with patient‑specific manufacturing processes and associated contamination control challenges.
• Commercial launch readiness experience.
• Experience supporting organizations transitioning from clinical‑stage manufacturing to commercial production.
• Experience supporting BLA, MAA, and Pre‑Approval Inspections (PAIs).
• Experience implementing and validating rapid microbiological methods.
• Advanced degree (MS, PhD, or equivalent) preferred.

Key Competencies

• Sterility Assurance
• Contamination Control Strategy (CCS)
• Aseptic Processing
• EU GMP Annex 1
• Environmental Monitoring
• Media Fills & Process Simulations
• Smoke Studies & Airflow Visualization
• Sterilization & Depyrogenation Validation
• Rapid Microbiological Methods
• Endotoxin, Sterility, Bioburden & Mycoplasma Testing
• Cleaning Validation & Disinfectant Qualification
• Regulatory Inspections & Audit Readiness
• Cell & Gene Therapy