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- Tasks: Join us as a Microbiology & Sterilisation Validation Engineer, ensuring quality and compliance in our processes.
- Company: Terumo Aortic is dedicated to enhancing healthcare through innovative medical solutions.
- Benefits: Enjoy a 14-month fixed term role with opportunities for professional growth and development.
- Why this job: Be part of a high-performance culture focused on continuous improvement and regulatory excellence.
- Qualifications: A degree in Life Sciences or Engineering and experience in microbiology labs are essential.
- Other info: This role involves working in a quality system-controlled environment with a focus on business continuity.
The predicted salary is between 36000 - 60000 £ per year.
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.
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Microbiology & Sterilisation Validation Engineer employer: Terumo Aortic
Contact Detail:
Terumo Aortic Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Microbiology & Sterilisation Validation Engineer
✨Tip Number 1
Familiarize yourself with the specific regulatory standards mentioned in the job description, such as ISO 1135 and ISO 11137. Understanding these standards will not only help you during the interview but also demonstrate your commitment to compliance and quality.
✨Tip Number 2
Highlight any experience you have with Laboratory Information Management Systems (LIMS) in your discussions. Being able to speak confidently about your past roles involving LIMS will show that you are well-prepared for the responsibilities of this position.
✨Tip Number 3
Prepare examples of how you've contributed to continuous improvement initiatives in previous roles. This could include specific projects or changes you implemented that enhanced quality or efficiency, which aligns perfectly with the expectations of this role.
✨Tip Number 4
Brush up on your knowledge of cleanroom and sterilisation validation processes. Being able to discuss your hands-on experience or theoretical understanding of these processes will set you apart from other candidates.
We think you need these skills to ace Microbiology & Sterilisation Validation Engineer
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Microbiology & Sterilisation Validation Engineer position. Make sure you understand the key responsibilities and required qualifications, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in microbiology labs, sterilisation processes, and quality systems. Use specific examples that demonstrate your skills and achievements related to the job requirements.
Showcase Your Skills: Make sure to highlight your analytical and problem-solving skills, as well as your proficiency in quality computer systems. Mention any relevant statistical techniques you are familiar with, as these are crucial for the role.
Craft a Strong Cover Letter: Write a compelling cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role and the company. Discuss how you can contribute to Terumo Aortic's quality objectives and continuous improvement initiatives.
How to prepare for a job interview at Terumo Aortic
✨Understand Regulatory Standards
Familiarize yourself with ISO 1135 and ISO 11137, as well as other relevant regulatory standards. Be prepared to discuss how your knowledge of these standards can contribute to maintaining compliance in the role.
✨Showcase Your Experience
Highlight your previous experience in quality system-controlled microbiology labs and any specific projects related to sterilisation and cleanroom validations. Use concrete examples to demonstrate your skills and achievements.
✨Emphasize Continuous Improvement
Discuss your approach to promoting a culture of continuous improvement. Share examples of how you've contributed to process enhancements or quality objectives in past roles.
✨Prepare for Technical Questions
Be ready to answer technical questions related to microbiology, sterilisation processes, and computer systems validation. Brush up on key concepts and be prepared to explain your thought process when solving problems.
