Terumo Aortic are currently seeking a highly skilled and motivated Microbiology & Sterilisation Validation Engineer to join our team on a 14 month fixed term basis. This role is integral to maintaining and enhancing our quality objectives, ensuring compliance with regulatory standards, and supporting continuous improvement initiatives. The successful candidate will play a key role in microbiology, sterilisation, and business continuity, working within a quality system-controlled environment. The main responsibilities of the role are; Quality & Compliance Maintain awareness of the relevance and importance of activities performed and their contribution to quality objectives. Promote a culture of high performance, continuous improvement, and regulatory compliance. Support the re-validation plan for sterilisation and microbiology. Assist in the site investment programme for sterilisation, microbiology, and business continuity. Microbiology Duties Administer the Laboratory Information Management System (LIMS). Oversee validation and change management of LIMS and other required computer systems. Validate and/or support validation of cleanrooms/controlled environments. Develop Quality Plans for any works impacting cleanrooms or controlled areas. Sterilisation Duties Validate and/or support validation of steriliser processes in accordance with ISO1135 & ISO 11137. Validate equipment and test methods. Business Continuity Duties Support site improvement/investment activities. Ensure compliance with change and document control processes. General Duties Provide computer systems validation support. Support the purchasing and validation of equipment. Participate in continuous improvement activities. Author and prepare procedures, work instructions, and other relevant documents. Raise, investigate, and complete non-conformance reports as required. Perform any other duties as necessary. The successful candidate will possess; Degree in Life Sciences, Engineering, or a relevant scientific discipline. Experience working in a quality system-controlled microbiology lab. Experience in steriliser and cleanroom validations. Working knowledge of computer system validation requirements. Proficiency in quality computer systems and Windows applications. Thorough knowledge of regulatory standards, Quality Management Systems, and global regulations for medical devices. Strong analytical and problem-solving skills, including the appropriate use of statistical techniques. Excellent facilitation, coordination, prioritisation, presentation, and communication skills. Proven ability to manage workload, meet deadlines, and work under pressure.