15 Apr, 2019
Industry : Engineering & Technical Job Location : Cheshire Job Reference : 13050CJ Job Category : Engineering Employment Type : Contract Posted : 26/04/2017 Salary & Benefits : 40 - 50 per hour Experience Required : See Job Description Education Required : See Job Description Please note you must be permitted to work in the EC to . Job Summary Our client are a FTSE 100 manufacturer, with multiple worldwide production facilities within the medical devices manufacturing sector. The company culture is one that heavily utilizes the Continuous Improvement model and requires a Validation Engineer to work through the companies production lines looking at process validation improvement. All the lines have been validated, but haven't been looking at in detail from an IQ, OQ and PQ improvement point of view. Job Description Validation Engineer 40 - 50 per hour - 6 Month Contract - 35hours per week This role is Monday to Friday with the occasional flexibility for longer hours or weekend work during periods of product and process trials. The Opportunity Our client are a FTSE 100 manufacturer, with multiple worldwide production facilities within the medical devices manufacturing sector. The company culture is one that heavily utilizes the Continuous Improvement model and requires a Validation Engineer to work through the companies production lines looking at process validation improvement. All the lines have been validated, but haven't been looking at in detail from an IQ, OQ and PQ improvement point of view. This role will help support the company with an exciting busy period of multi-million pound investment for the business at their site just outside Chester. The company are a keen advocate of employee engagement and Kaizen CI processes to work as a collective to develop new and existing products and processes that change the lives of their customers in over 100 countries. This company are currently in the process of adding 9 new production lines to the facility to take their number from 33 to 42.This will allow them to increase the number of new products the site can manufacture, to meet global demand, meaning it's a great time to join the company, add value and really make a difference. The Role You'll look after the facilities, process and software validation activities across the site working under their existing Validation Lead on site. You'll need minimal direction and supervision, but will always have a line manager present to ask question to seek advice from. Your role will be to create and manage documentation required for validation execution activities - including but not limited to F.A.T, IQ, OQ, PQ, SAT and PV. You'll also look at existing validation and try and acertain areas for improvement. Provide the coordination, creation and execution of validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support the manufacturing of automated equipment while working to 21CFR and will have plenty experience in GMP (good manufacturing practice) The Candidate Within this role you will have the ability to complete the following, * Creation and execution of Validation plans and validation protocols for projects. * Prepare and /or revise validation protocols/procedures as required. * Review and execute qualification and summary reports, write and revise as needed. * Work under the confines of the project schedule and budget. * Analyse validation data, prepare reports, and make recommendations for changes and or/improvements across different manufacturing lines. * Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity. * Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity. *Ensure the correct execution of FAT, SAT, IQ,OQ,PQ,PV * Interface with Manufacturing, Mechanical and Controls Engineering group. * Have an understanding of PLCs and HMIs pertaining to validation activities. * Innovate and use good judgement to incorporate applicable standards and regulatory requirements such as 21 CFR Qualifications/Experience The Ideal Validation Engineer will possess the following:- HNC/HND or equivalent within an engineering discipline Technical understanding of medical/pharmaceutical/food equipment validation requirements IQ,OQ,PQ qualification or equivalent Knowledge of GMP / Gamp5 requirements and current industry practices. The Package This role is paying: 40 - 50 per hour - 6 Month Contract Limited (Ends 31st October 2017) - 35hours per week This role is Monday to Friday with the occasional flexibility for longer hours or weekend work during periods of product and process trials. Job Keywords validation engineer, validation lead, contract, temp, fixed term, medical devices, pharmaceutical, food, FDA, IQ, OQ, PQ, FAT, SAT, CFR Bluefire Consulting is an equal opportunities Employment Business/Agency specialising in Engineering recruitment on a UK wide basis.