Sterility Assurance Engineer – Hybrid, Medical Devices

Corin Group; Cirencester; Hybride; GBP 27 000 - 31 000; Plein temps

Avantages offerts par ce poste

25 days annual leave

Bonus 7.5%

Pension scheme 6%→9.7%

Life assurance

Private medical insurance

Employee referral scheme

Professional development

Résumé du poste

Corin is seeking a Sterility Assurance Engineer in Cirencester, UK (Hybrid – minimum 3 days in the office after probation). This role sits in the Global Validation & Sterility Team, focusing on maintaining sterilisation, bioburden and cleanroom compliance within a regulated medical devices environment.

The role requires hands-on microbiology lab experience, knowledge of ISO 13485/FDA QSR, and collaboration with multiple internal teams to ensure patient safety and regulatory compliance.

Qualifications

• Degree in a Life Science discipline with microbiology focus.
• Hands-on microbiology laboratory experience.
• Experience with microbiological testing techniques and environmental monitoring.
• Knowledge of cleanroom operations and environmental control principles.
• Understanding of sterilisation processes and validation.
• Experience in regulated environments (medical devices/pharma/biotech).
• Familiarity with Quality Management Systems ISO 13485 and FDA QSR.

Responsabilités

• Develop, validate, maintain and monitor terminal sterilisation processes for implants per international standards.
• Maintain bioburden and endotoxin monitoring systems for Corin products.
• Evaluate products to determine sterilisation/bioburden/endotoxin validation needs.
• Support validation activities for new/modified instrumentation including sterilisation and cleaning.
• Manage environmental monitoring for cleanroom facilities including air, surfaces, water and materials.
• Coordinate with external contract laboratories to ensure timely testing.
• Review and approve laboratory test reports.
• Provide guidance on cleanroom operations and GMP compliance.
• Investigate environmental non-conformances and support CAPA activities.
• Monitor developments in sterility assurance and environmental control standards.
• Act as SME supporting Manufacturing, Product Development and Purchasing.
• Participate in internal and external quality audits.
• Maintain compliance with ISO 13485, FDA 21 CFR Part 820, GMP and Corin QMS requirements.

Connaissances

Hands-on microbiology

Environmental monitoring

Cleanroom operations

Sterilisation validation

cGMP compliance

ISO 13485 / FDA QSR familiarity

Analytical skills

Formation

Bachelor’s degree in Life Science (Microbiology preferred)

Description du poste

Corin is seeking a Sterility Assurance Engineer in Cirencester, UK (Hybrid – minimum 3 days in the office after probation). This role sits in the Global Validation & Sterility Team, focusing on maintaining sterilisation, bioburden and cleanroom compliance within a regulated medical devices environment.

The role requires hands-on microbiology lab experience, knowledge of ISO 13485/FDA QSR, and collaboration with multiple internal teams to ensure patient safety and regulatory compliance.