Sterilisation Validation

The Consultant will lead and support sterilisation strategy, validation, and compliance activities across the full lifecycle of medical devices, including Class IIa. The role requires deep expertise in sterilisation modalities, microbiological testing, and regulatory frameworks under both FDA and EU MDR.

Job Title: Sterilisation Validation

Duration: 12 months (with extension opportunity)

Location: Amsterdam, Netherlands (Remote)

Key Responsibilities:

• Sterilisation Strategy & Validation
• Develop and execute sterilisation validation plans using Ethylene Oxide (EtO), steam, radiation, and other methods.
• Ensure compliance with ISO 11135, ISO 11137, ISO 17665, ISO 14937, ISO 11737-1/-2, and EN 556-1 standards.
• Oversee cleanroom validation and bioburden/endotoxin testing protocols.
• Regulatory Compliance
• Align sterilisation processes with FDA 21 CFR Part 820 and EU MDR 2017/745 Annex I and VIII.
• Prepare documentation for CE marking, FDA submissions, and Notified Body audits.
• Support risk management activities per ISO 14971 and ISO 13485.
• Technical Support & Troubleshooting
• Lead root cause investigations for sterilisation failures and non-conformities.
• Advise on parametric release strategies and alert/action levels for cleanroom and microbiological monitoring.
• Cross-functional Collaboration
• Interface with R&D, manufacturing, and external sterilisation providers.

Required Qualifications:

• Advanced degree in microbiology, biomedical engineering, or related field.
• Familiarity with ISO/AAMI/ASTM standards and FDA guidance documents.
• Strong documentation, analytical, and communication skills.