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Senior Sterility Engineer visa can be sponsored for this job


NES FIRCROFT

2021-12-03 09:01:05

Job location Thetford, Norfolk, United Kingdom

Job type: fulltime

Job industry: Engineering

Job description

Senior Sterility Engineer

Medical Devices

Norfolk

Contract

Senior Sterility Engineer

My Client is looking for a Sterility Assurance Engineer to join their team responsible for the qualification of fluid load moist heat sterilization systems for medical products and devices. Your primary focus will be to endure product quality, safety, efficacy and compliance to regulatory requirements (PICS / Annex 17) for all product sterilised at the site.

You will be working in collaboration with the engineering teams in addition to the sterility assurance microbiology team, ensuring suitable procedures and specifications are formulated and deployed within the important field of sterilisation.

Essential Responsibilities:

Lead the Heat Study group to ensure that all Sterilisation equipment and load combinations are requalified as required and provide a system of managing this critical system.
Critical sterilisation instrument calibration, to traceable standards.
Maintaining the validated state of sterilisation equipment by documented control of engineering and other extraneous functions, utilities and services.
Involved in the review, assessment and disposition of deviations and non-conformances, atypical sterilisation events, REWO, change requests, validation and study protocols and investigation of complaints.
Share accountability with microbiology and engineering for sterility assurance performance and parametric release at the site.
Thermometric condition and Biological Indicator analysis of developed cycle in conjunction with Microbiology departments
Conduct trending with application of predictive maintenance techniques, to enhance and stabilize preventative maintenance strategy and frequency.
Ensure continuous improvement of site operations through a formal program, resources, metrics and accountability.
Report sterility assurance performance monthly and take actions to address misses. Establish communication operation mechanism to keep senior leadership informed of both leading and lagging performance in relation to sterilisation.
Maintained inspection / audit readiness of the function, including the documentation / records. Represent critical sterility assurance function during local, corporate, and regulatory auditing systems
Ensure a safe working environment and practices

Qualifications:

Deep knowledge in all sterility assurance activities: audits, batch release, CAPAs, investigations, complaints, risk management and validation
Experience in quality activities
Expertise: sterilisation and validation
This highly collaborative environment provides for an exciting opportunity to make a difference, so ensure to apply now to be considered for the role. Further information can be supplied on request.

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.

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