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Validation Engineer job in St Ives

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Job Ref:  68581692
Employer:  My Job Matcher
Country:  United Kingdom
City:  St Ives
Post Code:  BH24
11/10/2016 16:37
RHL, a specialist in Design, Engineering & Manufacture talent acquisition, are currently recruiting for; Title: Validation Engineer Location: Cambridge Status: Permanent Contact: Rachel OliverReference No: 227029 Our client, a multidisciplinary consultancy in Cambridge, is having great success and going through a huge period of organic growth. As they look to nearly double their existing workforce they are looking for a Validation Engineer to play an integral part in the newly formed Quality Standards team. This is a fantastic alternative for an individual who is working in-house with a global medical devices or pharmaceutical manufacturer. You will be involved in a larger array of projects, with regular travel overseas required. You will be part of an incredibly vibrant, social environment. They encourage individuals to highlight ideas, and can facilitate that process. Role of the Validation Engineer Working within our multidisciplinary teams on major development projects, you will be responsible for the development, evaluation and validation of manufacturing processes both at the company and at clients primarily in the pharmaceutical and medical sectors. You will have exposure in developing the necessary regulatory documentation including risk management, design inputs, outputs, design verification and validation, DMR, etc. Requirements of the Validation Engineer 2.1 or above in a Science/Engineering disciplineExperience with automated assembly equipment including procurement, set up and validationExperience of building requirements specificationsExperience of medical process validation DQ, IQ, OQ, PQ and methods such as DOEExperience in ISO 14971 - Application of Risk Management to Medical DevicesRisk Management Files; Plans, Hazard Assessments, Design FMEA, Process FMEAExperience with injection moulding, tooling and machineryWorking to ISO 13485, ISO15378 and 21CFR820 quality requirementsExperience in API/Final Product Pharmaceuticals environmentsConversant in Current GMP and Engineering GuidelinesExperienced working in design teamsExposure of Design History File Documents; Plans, Design Inputs, Verification, Validation, Design Reviews, Design OutputsAbility to lead projects, taking responsibility for quality, time and profit Please apply to Rachel Oliver, Senior Recruitment Consultant, , Recruitment Holdings Ltd (RHL) acts as an Employment Business and as an Employment Agency.
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