Validation Engineer II in Oradea

Purpose Statement: The Validation Engineer is responsible for leading the site in planning and executing equipment, process and product validations in accordance with all applicable regulations, standards and customer requirements.Key Job Accountabilities:Maintain the site Validation Master List (VML)Determine the validation strategy for product Validation Master Plans (VMP) in accordance with sector specific and customer requirementsSupport the maintenance and update of product VMPsTrain identified users in the validation processCoach trained users in best practices and the use of appropriate statistical analysis tools to develop validation skill set at the siteProvide practical expertise and technical guidance in creation and execution of validation protocolsDetermine and coordinate validation activities required as a result of site changesProvide timely review and approval of validation documentationMaintain a working knowledge of all validation requirements, practices, procedures and industry trends for validation process and development.Escalate issues and roadblocks that are preventing progress and successMaintain and report validation metricsProvide data and SME input in to the site Quality System Management Review, Metric Dashboard and Operations reviews as appropriateAdditional Accountabilities:Support site internal auditsSupport customer visits and auditsSupport external registration or agency audits and Regulatory Inspections.Actively Participate in the Global Validation user Group.Acknowledges and complies with the requirements of ISO 9001, ISO 14001 and ISO 45001 standards provided in the procedures and instructions that are specific to each field, documentation that underlies the proper functioning of the integrated management system of quality, environment, safety and occupational health.Additional duties as assigned.Education/Experience Qualifications:A minimum of a Bachelor’s degree is preferredExperience of minimum 2 years is required for this positionExperience of executing validation activities in a regulated environment is requiredStrong working knowledge of Regulatory and Standard requirements for validation is requiredExperience with direct customer interaction is preferredExperience as OTJ trainer/coach preferredAn equivalent combination of education and experience sufficient to successfully perform the key job accountabilities may be considered.Other Qualifications: Employee must be self-motivated with the ability to work independently and in a team environment.Employee must be experienced in giving training both in classroom setting and in 1:1 on the job environmentGood oral and written communication skills are necessary.Attention to detail, and computer literacy are essential.Project Management knowledge is advantageous.General office equipment and materials.Work Environment:The work setting should consist of an office environment with suitable lighting, comfortable temperatures, and a low noise level.


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