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A position with responsability within a leading international companyPersonal development through learning on the job and additional external trainingsA market oriented compensation, including a range of fringe benefits For one of our medical devices partners in Switzerland, we?re currently looking for a Validation Engineer. He or she will provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods and environment and ensure that all compliance issues and internal requirements are addressed.Manages complexity and technical accountabilityServes as technical expert for the validation process and responsibilities to ensure complianceResolves and manages technical operational problems in area of expertiseSuggests, encourage and coordinate innovation and continuous improvement within the validation processImplements initiatives in the validation process that will deliver customer value at lowest costFacilitates successful team behavior within Quality Systems and across functional areasManages relationships externally and internallyBuilds cross-functional and cross-departmental support, fostering overall effectivenessFosters harmony within Quality SystemsInfluences and persuades so as to bring about technical and process improvementsEnsure accuracy and maintenance of the Validation Master PlanReview and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exerciseEnsure all validation activities and documents are authorized and appropriate compliance approval is gainedEnsure that all validation activities are carried out and reported in a timely mannerEnsure compliance through assisting in auditsCompany:Pauwels Consulting is a fast-growing technical consultancy firm with a large portfolio of international corporate clients in Engineering, Pharma and IT. We deliver consultancy and turnkey projects to leading companies in Belgium and beyond.At Pauwels Consulting we value your talent and ambitions. That is why we invest heavily in the continuous education, personal coaching and individual development of all our consultants. At Pauwels Consulting, you will find a challenging and inspiring work environment every single day.Are you interested in working for top companies in your industry and do you like to improve your skills and expertise every day? Then we should definitely meet! We look forward to hearing from you via phone (+32 9 324 70 80) or e-mail (email@example.com).
Verantwoordelijke productiemethodes en industrialisatieBachelor or Master?s degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification) with a broad technical or educational skills baseMinimum of 2 to 5 years of experience in working in a regulated industry of which 2 years have been spent carrying out validationsWorking experience of validation computer systems for use in a FDA regulated environmentExperience in validation of manufacturing process in medical device and pharma environmentExperience with processes occurring in clean roomsProcess knowledge and documentationMust be able to lead and give direction to validation projects and teamsDesirable: in depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industryLanguages: German and English spoken and written
SolliciterenWoodrow Wilsonplein 16, 9000 GENT Laila Bajwa 3293247080