Sterility Assurance Specialist

About the role

We are seeking a Sterility Assurance Specialist to provide technical expertise in sterility assurance, environmental monitoring and microbiology for a leading pharmaceutical manufacturer. The role supports aseptic manufacturing operations and ensures compliance with GMP requirements.

Key responsibilities

• Maintain sterility assurance and environmental monitoring programmes in line with current GMP standards.
• Lead investigations into microbiological deviations, non‑conformances, quality incidents and customer complaints, delivering root‑cause analysis and corrective actions.
• Provide technical guidance on contamination control, interpret microbiological data and trend environmental monitoring results.
• Support validation activities, develop microbiological methods and oversee work of external microbiology laboratories.
• Deliver microbiology and aseptic training and drive continuous improvement across manufacturing sites.

Required profile

• Degree in Microbiology or related scientific discipline, or equivalent industry experience.
• Experience in a sterile or aseptic pharmaceutical manufacturing environment.
• Strong knowledge of environmental monitoring, contamination control and sterility assurance principles.
• Proven ability to investigate microbiological deviations, OOL results and implement CAPAs.
• Excellent communication, problem‑solving and stakeholder management skills.

Required skills

• Environmental monitoring
• Microbiological data interpretation
• Method development
• Validation activities
• CAPA implementation
• Contamination control