Microbiology & Sterilisation Validation Engineer

Terumo Aortic are currently seeking a highly skilled and motivated Microbiology & Sterilisation Validation Engineerto 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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