Must possess expertiseknowledge sufficient to adequately perform the duties of the job being offered. Expertiseknowledge may be gained through employment experience or education. Such expertiseknowledge cannot be quantified by time. Required expertiseknowledge includesbr br Experience with current US and international regulations, industry guidance and bestpractices for the qualificationvalidation of facilities, utilities, equipment and process support commercial manufacturing.br Project management experience.br Experience in direct interaction with FDA.br Engineering skills and operational knowledge in the identification and resolution of technical problems in the execution of commissioning and qualification activities.br Experience supporting several projects occurring at the same time by keeping abreast of the activities, reviewing test results and monitoring the work to anticipate any problems and gauge their level of involvement from a technical support perspective.br br The years of experience listed in H.6 and H.10 do not apply to the required skills listed in this section.br Employer will accept any suitable combination of education, training, or experience.
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