Principal Scientist - Microbiology & Sterilization

About the role

We are seeking a Principal Scientist with deep expertise in microbiology and sterilization to lead global programs across multiple manufacturing sites. The role will shape best practices, drive harmonisation, and influence quality and sterility assurance in a highly regulated healthcare environment.

Key responsibilities

• Act as the global subject‑matter expert for microbiology, environmental monitoring, contamination control and sterilization processes.
• Develop and implement global microbiological remediation and maintenance strategies across facilities and business units.
• Lead technical investigations of microbial excursions, contamination events and sterility assurance concerns.
• Oversee environmental monitoring programmes, analyse data trends and drive corrective actions.
• Provide scientific leadership for sterilization validation, re‑qualification and routine monitoring for EO, radiation, steam and other modalities.
• Support facility design, qualification and continuous improvement of microbiological controls.
• Author and approve technical reports, protocols, risk assessments and validation documentation.
• Represent the organisation during regulatory inspections, audits and customer audits.

Required profile

• Extensive experience in microbiology, environmental monitoring, contamination control and sterilization within a regulated healthcare or medical‑device setting.
• Proven ability to lead global programmes and drive technical investigations.
• Strong knowledge of FDA, ISO, EU MDR and GMP requirements.
• Excellent scientific communication and documentation skills.

Required skills

• Microbiology and microbial risk assessment
• Environmental monitoring and data trend analysis
• Sterilization validation (ethylene oxide, radiation, steam)
• Contamination control strategy development
• Regulatory compliance (FDA, ISO, EU MDR, GMP)
• Technical report writing and protocol authoring