|Job Ref:||204611735||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||City:||St. Ives||Address:||Salary:||£35000 - £55000/annum||Post Date:||24/10/2016 10:58|
RHL, a specialist in Design, Engineering & Manufacture talent acquisition, are currently recruiting for;|
Title: Validation Engineer
Contact: Rachel Oliver
Reference 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 discipline
* Experience with automated assembly equipment including procurement, set up and validation
* Experience of building requirements specifications
* Experience of medical process validation DQ, IQ, OQ, PQ and methods such as DOE
* Experience in ISO 14971 - Application of Risk Management to Medical Devices
* Risk Management Files; Plans, Hazard Assessments, Design FMEA, Process FMEA
* Experience with injection moulding, tooling and machinery
* Working to ISO 13485, ISO15378 and 21CFR820 quality requirements
* Experience in API/Final Product Pharmaceuticals environments
* Conversant in Current GMP and Engineering Guidelines
* Experienced working in design teams
* Exposure of Design History File Documents; Plans, Design Inputs, Verification, Validation, Design Reviews, Design Outputs
* Ability to lead projects, taking responsibility for quality, time and profit
Please apply to Rachel Oliver, Senior Recruitment Consultant,, (Apply online only)
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