Sterility Assurance Engineer

Corin Group; Cirencester; Hybrid; GBP 27,000 - 31,000; Full time

Benefits offered by this job

25 days annual leave

Bonus 7.5%

Pension scheme 6%→9.7%

Life assurance

Private medical insurance

Employee referral scheme

Professional development

Job summary

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.

Responsibilities

• 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.

Skills

Hands-on microbiology

Environmental monitoring

Cleanroom operations

Sterilisation validation

cGMP compliance

ISO 13485 / FDA QSR familiarity

Analytical skills

Education

Bachelor’s degree in Life Science (Microbiology preferred)

Job description

Sterility Assurance Engineer

Location: Cirencester, UK (Hybrid - minimum 3 days per week in the office after probation)
Contract: Permanent

Join Corin and Help Shape the Future of Orthopaedics

Are you an experienced microbiology or sterility assurance professional looking to make a real impact in the medical device industry? Do you have hands‑on laboratory experience and a strong understanding of cleanroom environments, environmental monitoring, sterilisation validation, and regulatory compliance?

If so, we have an exciting opportunity to join our Global Validation & Sterility Team as a Sterility Assurance Engineer.

At Corin, we're transforming orthopaedic surgery through innovative robotics, AI‑powered technologies, and clinically proven implant solutions. As part of our growing global business, you'll play a critical role in ensuring our products meet the highest standards of sterility assurance, quality, and patient safety.

About the Role

As a Sterility Assurance Engineer, you will be the microbiological subject matter expert within the business, supporting the ongoing regulatory compliance and effectiveness of Corin's Sterility Assurance Programme.

Working closely with Manufacturing, Product Development, Quality, and external testing laboratories, you will be responsible for maintaining and improving sterilisation, environmental monitoring, bioburden, endotoxin, and cleanroom compliance programmes.

This role is ideal for someone with transferable experience from the medical device, pharmaceutical, biotech, or related regulated industries who is looking to develop their career within a forward‑thinking organisation.

What you’ll do

• Develop, validate, maintain and monitor terminal sterilisation processes for implants in accordance with current international standards.
• Develop and maintain systems for bioburden and endotoxin monitoring of Corin products.
• Evaluate new and modified products to determine sterilisation, bioburden and endotoxin validation requirements.
• Support validation activities for new and modified instrumentation, including sterilisation and cleaning processes.
• Manage environmental monitoring programmes for Corin's cleanroom facilities, including microbiological monitoring of air, surfaces, water and processing materials.
• Liaise with external contract laboratories to ensure testing is completed in a timely and compliant manner.
• Review, assess and approve laboratory test reports.
• Provide guidance on cleanroom operations and cGMP compliance.
• Investigate environmental non‑conformances and support CAPA activities.
• Monitor developments in sterility assurance and environmental control standards to ensure ongoing compliance.
• Act as a subject matter expert supporting Manufacturing, Product Development and Purchasing teams.
• Participate in internal and external quality audits.
• Maintain compliance with ISO 13485, FDA 21 CFR Part 820, GMP and Corin Quality Management System requirements.

What We're Looking For

Essential

• Degree in a Life Science discipline (Microbiology preferred).
• Hands‑on microbiology laboratory experience.
• Experience of microbiological testing techniques and environmental monitoring.
• Knowledge of cleanroom operations and environmental control principles.
• Understanding of sterilisation processes and sterilisation validation.
• Experience working within a regulated environment such as medical devices, pharmaceuticals or biotechnology.
• Knowledge of Quality Management Systems, including ISO 13485 and/or FDA QSR requirements.
• Strong analytical, organisational and problem‑solving skills.

Desirable

• Experience supporting CAPA investigations and root cause analysis.
• Internal auditing experience.
• Understanding of endotoxin and bioburden testing methodologies.
• Experience working with external testing laboratories.

Why Join Corin?

For nearly 40 years, Corin has been improving lives through innovation in orthopaedics. Our unique combination of advanced robotics, AI‑enabled technologies, and clinically proven implants allows us to deliver better outcomes for patients, surgeons, and healthcare providers around the world.

Join a business where your expertise directly contributes to improving patient care and advancing medical technology.

Benefits

In addition to a competitive salary and hybrid working model, we offer:

• 25 days annual leave plus bank holidays
• Competitive Salary £27,000 - £31,000 plus 7.5% Bonus
• Excellent pension scheme starting at 6%, increasing to 9.7% after 18 months
• Life assurance (6x annual salary)
• Private medical insurance with BUPA for you and your family
• Employee referral scheme paying from £1,000 per successful referral
• Opportunities for professional development and career progression

Apply Today

If you're passionate about microbiology, quality, and ensuring the highest standards of patient safety, we'd love to hear from you.

Our people and products change people's lives. Connect your career ambition to our vision and join Corin on our journey of innovation.