We’re looking for an experienced Sterility Assurance Engineer to join our Global Validation and Sterility team on a permanent contract. This is a fantastic opportunity for someone with lab experience to join our team and support with the facilitation of testing and review of technical reports. Ideally you will have transferable experience from a cleanroom environment. As the Sterility Assurance Engineer you will be responsible for the microbiological aspects of the operation and ongoing regulatory compliance of the Sterility Assurance programme for Corin products. The key results areas for the role are the compliance of sterility assurance and related environmental control activities, with all applicable standards and requirements e.g. MDD, QSR and ISO 13485. The role offers a hybrid working model, with a minimum of 3 days based in our Global HQ in Cirencester Corin is a growing global orthopaedic innovation business, with a vision to revolutionize the field, by integrating advanced robotic and AI technologies (Apollo, OMNIBotics and OPS) for planning, implementation, and continuous learning with its unique combination of clinically proven hip and knee implants. The key responsibilities of the Sterility Assurance Engineer include (but are not limited to):• Develop and maintain documented systems for the validation and routine monitoring of the terminal sterilisation process for implants, in accordance with current editions of International Standards, and ensure that the routines are executed and reported. • Develop and maintain procedures and methods for monitoring the pre-sterilisation Bioburden of Corin implants. • Develop and maintain procedures and methods for monitoring the Endotoxin of Corin implants. • Evaluate new and modified implants in relation to the established procedures for sterilisation, Bioburden and Endotoxin and update validation requirements, systems and documentation as required.• Evaluate new and modified instrumentation in relation to the established procedures for sterilisation and cleaning, and update validation requirements, systems and documentation as required.• Develop and maintain documented systems for compliance and monitoring of the Corin Cleanroom, in accordance with current editions of international standards, and ensure that routines are executed and reported. In addition to physical tests, this will also include the microbiological monitoring routines for air, surfaces, water and any other processing substances.• Liaise with contract Test Laboratories to ensure timely and compliant processing of test samples. Review, appraise and approve Test Reports.• Monitor and advise on Cleanroom operations, and associated activities which impact the Cleanroom and product Sterility Assurance, to ensure a high level of compliance and cGMP are maintained.• Maintain the Environmental Non-Conformance Report system and participate in troubleshooting and CAPA activities associated with Sterility Assurance activities.• Monitor developments in the field of Sterility Assurance and environmental control for the impact and compliance of Corin processes.• SME resource for Manufacturing, Product Development and Purchasing.• Maintain all appropriate records.• Carry out internal and external Quality Audits as per business requirements.• Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820.• Ensure that process & timeline requirements for Corrective & Preventive Actions (CAPA) are met in accordance with Corin’s Standard Operating Procedures (SOP’s) and in support of Corin’s Global Objectives for CAPA. Skills and Experience• A degree level education in a life science subject (microbiology preferred).• Hands-on experience of microbiological techniques.• A good understanding of environmental control, clean room operations, sterilisation processes, sterilisation validation in the pharma, biotech or medical device industries.• Knowledge of Quality Management Systems i.e. FDA QSR, ISO 13485. Corin is a growing global orthopaedic innovation business, with a vision to revolutionize the field, by integrating advanced robotic and AI technologies (Apollo, OMNIBotics and OPS) for planning, implementation, and continuous learning with its unique combination of clinically proven hip and knee implants. Since its inception nearly 40 years ago, Corin has strived to maximize healthcare value by providing a fast, positive, and assured return to the quality of life for people all over the world. Our revolutionary technologies enable patients, surgeons, and healthcare providers to connect more closely than ever. For further information on who we are, our products and services, please visit www.coringroup.comIf you want to be part of our journey, join us as “Our people and products change people’s lives, connect your career ambition to our vision” Our benefits, what’s in it for you:In addition to your salary, support and opportunity to work in a hybrid environment you will also receive• 25 days holiday plus bank holidays• Excellent pension – starts at 6%, going up to 9.7% after 18 months.• Life assurance – Six times your basic salary• Private medical insurance with BUPA for you and your family• Free annual eye tests and flu vaccinations• Employee referral program where you can earn up to £1,000 for each successful hire you recommend Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.