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Senior Computer Systems Validation EngineerRef: 23909

Salary:£35 - £46 per hour

Added:08 Jan 2019

Region: Scotland

Sector: Pharmaceutical

Sub Sector: Clinical IT

Job Summary: An excellent opportunity has arisen for a Senior Computer System Validation Engineer. Looking for the right candidate to join their team based in Inverness. As the Senior Computer System Validation Engineer, you will lead a team of engineers with expertise in CSV providing initiative and leadership to implement systems and processes that are aligned with the overall quality and business vision in compliance with the applicable regulatory and requirements. You should be able to provide a high level of technical knowledge and practical experience of Computer Systems and Computer Software Validation, which includes, automated manufacturing systems, automated quality systems and tools, computer applications for business, bespoke computer software specification, design and systems testing. Requirements: Degree qualification in an appropriate engineering discipline SME knowledge of computer systems & software design, development and validation Advanced formal problem solving techniques, e.g. PeX Black Belt certification Risk management tools e.g. FMEA, SRA, DOE Working knowledge of design control Working knowledge of FDA & European Regulations relating to the Medical Devices Industry and best practices guidelines i.e. 21 CFR Part 11, 820 & ISO 13485 and GAMP Experience on computer systems and software development validation and/or testing activities, a minimum of 3 of these years must be from working in a regulated industry As well as excellent career progression and exposure, a competitive salary with a range of benefits including life insurance, health cover, pension and bonus will be provided. For further details about this role, or other roles within Medical writing and Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk

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