sterility assurance specialist in leeds

31 October 2018
ruby willard, randstad cpe
job type
£ 28,000 - £ 33,000 per year
apply now

leeds, yorkshire and the humber
sub specialism
Research and Development
job type
working hours
£ 28,000 - £ 33,000 per year
reference number
ruby willard, randstad cpe
apply now

job description

Are you an experienced Sterility Assurance Specialist? Are you looking to take on a new challenge with a leading Medical Devices Manufacturer? If so we are looking for individuals just like you!

You will be supporting the Sterility Assurance and Microbiology team in the application and practice of microbial assurance as applied to the design, manufacture and sterilisation of implants while ensuring that the company meets all corporate, FDA, department of health & medical device directive and European standards requirements.

This opportunity is a contract role, initially for 15 months, working 37 hours per week Mon-Fri.


* To support the microbial assurance aspects of the Quality System
* To carry out regular microbial monitoring of all clean room facilities and water systems, to analyse the results and recommend corrective action where appropriate
* To co-ordinate use of all microbial services
* To support the review and development of procedures for all microbial assurance activities
* To carry out regular internal auditing of all clean room facilities and other areas
* To implement the GMP training program for clean room and other appropriate staff
* To be a member of New Product Development teams and undertake cleaning, microbial, sterilization validation as required
* To support the release of sterile products
* To support the Quality team in the preparation for and performance of all third party inspections and audits as appropriate
* To create change controls identifying Microbial impact and necessary actions in line with worldwide and local procedures
* To adhere to the Company's procedures as detailed in the SOP manual
* Maintain a detailed knowledge of AAMI/ISO standards relevant to Sterilization and Environmental monitoring
* To support specific projects as allocated by the International Sterility Assurance Manager
* All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform

Qualifications / Experience required:

* Degree level qualification grade 2:1 or higher, in one of the following areas: Medical Engineering, Mechanical Engineering, Biomedical Sciences, Microbiology or BioEngineering


* ISO 9001 Lead Assessor qualification
* Post qualification experience as a Microbiologist 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

If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.