Job Opportunity

Reference: QS0971
Title: Sterility Quality Assurance Engineer
Location: Thetford
Job Type: 6 months
Salary: The PAYE rate is £20.96 per hour
Contact Person: Miss Selina Thompson apply@qualitystart.co.uk

Opportunity: Are you currently working in sterility quality assurance within the medical device or pharmaceutical industry? Have you validated and calibrated medical device equipment? Want to work for a global pharmaceutical manufacturing company with potential of further opportunities? If yes then this is the role for you.

Your role as a Sterility Quality Assurance Engineer based in Thetford will involve validating and calibrating fluid load moist heat sterilization systems for medical products and devices. You will ensure product quality, safety, efficacy and compliance to regulatory requirements PICS / Annex 17 for all products sterilised at the site.

Working in collaboration with the engineering teams and sterility assurance microbiology team to assure appropriate procedures and specifications are developed and deployed in the sterilisation area.

Duties and responsibilities include:

• Leading the Heat Study Group to ensure that all Sterilisation equipment and load combinations are requalified.
• Critical sterilization instrument calibration, to traceable standards.
• Maintaining the validated state of sterilisation equipment by documented control of engineering and other extraneous functions, utilities and services.
• The review, assessment and disposition of deviations and non-conformances, atypical sterilisation events, REWO, change requests, validation and study protocols and investigation of complaints.
• Thermometric condition and Biological Indicator analysis of developed cycle.  
• Trending with application of predictive maintenance techniques, to enhance and stabilize preventative maintenance strategy and frequency.
• Deployment of Lean / 6S principles (EMS).

This is a 6 months contract which will be reviewed for a possible extension dependent on the candidate and the business performance.  The PAYE rate is £20.96 per hour.

Skills:  To apply for the role of Sterility Quality Assurance Engineer you will have the following:

• Deep knowledge in all sterility assurance activities such as audits, batch release, CAPAs, investigations, complaints, risk management and validation.
• Sterilization and Validation experience with medical devices.
• Experience in or involved in all Quality activities.

How to Apply: In order to apply for this vacancy please ensure you have read and agree to the privacy policy found here and then email your CV to apply@qualitystart.co.uk quoting the reference number and the job title.