Senior Sterilisation Scientist
Location: Leeds
Employment Type: 6-12 Month Initial Contract
Salary: £comp

Clinical Professionals have recently registered a new vacancy from one of the world’s largest consumer health companies, who is looking for a Senior Sterilisation Scientist to join their team in Leeds for an estimated initial contract of 6-12 months, with the potential for a more permanent appointment.

Essentially you would be appointed as the company’s expert on the application and practice of microbial assurance as applied to the design, manufacture and sterilisation of orthopaedic products within their Leeds facility, where you will interact as a member of the Quality Assurance team in an office environment. As a primary directive you would need to ensure that the company meets all internal and regulatory requirements including, but not limited to: US FDA, Medical Device Directive and European Standards.

As an expert sterilization scientist you would be required to interface with a number functions in order to maintain a high degree of microbial assurance throughout the facility; these will include:
• Quality Assurance / CMW Microbiology / Production Managers
• Production / Packaging / Bioengineers Engineers
• Maintenance Supervisor / Cleaning and Packaging Staff
• Sterilisation Subcontractors / Packaging, and Clean room Equipment suppliers
• Sterilisation Sciences personnel

Essential Functions will include:
• To implement the microbial assurance aspects of the Quality System
• To carry out regular microbial monitoring of clean room facilities, to analyse results and recommend corrective actions where appropriate
• To oversee/co-ordinate the use of all microbial services
• To review and develop procedures for all microbial assurance activities
• To carry out regular internal auditing of all clean room facilities and other defined areas
• To implement the GMP training programme for clean room and other appropriate staff
• To validate gamma, ethylene oxide and gas plasma sterilisation processes for existing and new products to EN standards
• To develop alternative technologies that could be applied to future products
• To regularly audit sterilisation, packaging and clean room clothing suppliers
• To provide advice and guidance on new packaging technologies, and validations, and to keep abreast of corporate requirements
• To validate all microbial aspects of new products and packaging
• To adhere to the company’s standard operating procedures
• Some participation in internal auditing procedures

To qualify as an ideal applicant you would need to be able to evidence the following additional criteria:

•Skills and Abilities
•Minimum of three years as a microbiologist in a medical, pharmaceutical, or similarly regulated industry is required. Should also be familiar with microbiological aspects of GMP regarding medical devices, and auditing practices for relevant internal and external audits
•Personal Traits
•A degree in Microbiology required and preference will be shown to candidates with a familiarity with regulated industry and quality systems experience
•Must have the initiative and ability to investigate, plan and execute those actions required to constantly improve and develop the company’s microbial assurance levels
•An organised, and logical approach to training, documentation, and audit requirements is also essential, as is a professional approach when dealing with internal, corporate, regulatory or supplier representatives

Should you be actively looking for a new position or are simply interested in exploring this position and/or any other roles that we are currently handling further, please contact Suhail Hameed on +44 (0)2078221710. Alternatively, please send your CV via email to suhail.hameed@clinicalprofessionals.co.uk – Please note that if you haven’t been contacted within 48 hours, you have been unsuccessful on this occasion

If you do not feel that this position are right for you and know of someone who could be interested, please forward these details on as we have a generous referral scheme in place should we then go on to place someone that you refer to us.