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PRODUCTION / PROCESS ENGINEER - TYNE & WEAR - 25-30K + package
A new opportunity has arisen for the role of a Manufacturing Machine Validation Engineer within Quality Assurance for a
global manufacturer. The job exists to document demonstrated proof that equipment, processes and products will
consistently lead to the expected results.
Job Responsibilities:
* Develop the Division's validation plans to Design, Installation, Operational and Performance Qualification formats
predominantly for the qualification and validation of existing and new equipment, manufacturing processes and products.
* Assist with divisional equipment, manufacturing processes and product improvement projects, in conjunction with QA
Engineering.
* Responsible for developing divisional protocols using a risk based approach that meets current regulatory requirements
and industry practices.
* Undertake all key activities integral to the role which include: operating equipment, running trials, arranging for
test work and fault finding.
* Write all validation reports and studies for approval by Technical, Operations and QA Managers.
* Provide advice and guidance, where necessary, on validation reports produced by engineers and technicians.
* Objectively analyse and present data using quality tools to improve process performance and to investigate problems,
thereby identifying root causes and subsequent corrective actions.
* Provide process engineering support as required.
Qualifications, Skills & Experience:
* Qualified to HNC or degree level in an engineering or manufacturing related subject.
* Proven process quality experience in a high volume manufacturing environment.
* Working knowledge of machine validation and its principles
* Knowledge of six-sigma principles would be an advantage.
* Numerate and computer literate, including the use of Minitab.
* Exposure to GMP principles and experience of working in a clean room would be of benefit but not essential
* Willing to work within a HPT/team based environment actively contributing to areas of improvement.
validation manufacturing production engineer
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