Jobs

Microbiology Scientist - Yorkshire

Scientific & Laboratory
Ref: 457 Date Posted: Tuesday 20 Jul 2021
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Description:

 The purpose of this role is to support the Microbiological Quality and Sterility Assurance team in the application and practice of microbial assurance as applied to the design, manufacture, cleaning, and sterilization of orthopedic medical devices. Sterility Assurance support base business operations by environmental, water and product monitoring whilst supporting process changes, new product introductions and validation of equipment ensuring that the company meet all applicable quality and regulatory requirements.

 

ORGANISATIONAL INTERFACES:

Regional and international Sterility Assurance Teams, Inspection, Cleaning & Packaging operations staff, Sterilization and test Laboratory Sub-Contractors, Quality Engineers, New Product Development Engineers, Manufacturing, Maintenance and Process Engineers.

 

MAIN DUTIES & RESPONSIBILITIES:

1. To support the microbial assurance aspects of the Quality System.

2. To carry out regular microbial monitoring of all clean room facilities and water systems, to analyze the results, draft quarterly reports and recommend corrective action where appropriate.

3. To co-ordinate use of all microbial services, test labs, irradiators, and laboratory services

4. To support the review and development of procedures for all microbial assurance activities.

5. To carry out regular internal auditing of all clean room facilities and other controlled areas.

6. To be a member of New Product Development teams and undertake equivalency assessments or cleaning validation, and sterilization validation as required.

7. To write performance qualification protocols for clean line validations, new product introductions and sterilization validations

8. To support the Quality team in the preparation for and performance of all third party inspections and audits as appropriate.

9. To create change controls identifying Microbial impact and necessary actions in line with Worldwide and local procedures.

10. To adhere to the Company’s procedures as detailed in the SOP manual.

11. Maintain a detailed knowledge of AAMI/ISO standards relevant to Sterilization and Environmental monitoring.

12. To support specific projects as allocated by senior scientist, UK supervisor and/or the International Sterility Assurance regional team.

13. Worldwide deployment support for enterprise wise projects to increase sustainable manufacturing practices and provide an improved, harmonized cleanroom cleaning and disinfection program across our client.

14. All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.

 

KEY COMPETENCIES REQUIRED:

 

High Attention to Detail Pro-active approach to Work,

Project management experience Technical Writing skills

High Standards Flexible

Excellent Communication Skills Team Player

High level of Numeracy Highly Computer Literate

Planner & Organiser Bright

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QUALIFICATIONS & EXPERIENCE

 

ESSENTIAL:

 

Degree level qualification grade 2:1 or higher, in one of the following areas:

 

• Medical Engineering/Tissue Engineering

• Biomedical Sciences/Biomedical Engineering

• Microbiology

• Bioengineering

 

DESIRABLE:

 

• Master or PhD qualifications in relevant scientific or engineering fields

• Experience writing qualifications and/or validations

• Post qualification experience as a Microbiologist or biomedical scientist in a medical device, pharmaceutical, or similar regulated industry.

• Familiarity with microbiological aspects of GMP regarding sterile medical devices.

• Experience of conducting GMP audits, internal and relevant external audits.

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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