validation engineer – Raleigh, NC


validation engineer

Intellilink Technologies

Raleigh, NC

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Job Descriptionn

Working knowledge of cGMP guidelines, FDA 21 CFR Partn820/210/211, ICH guidelines and other international regulatory requirements. HVAC system Commissioning, control facilities temperature andnrelative humidity mapping, facilities Qualificationnand Validation activities.Scheduling, planning and executionnof validation projects for plant utilities, facilities and process equipment.  Apply thorough understanding of cGXPs, relevant plans and SOPs,nroutine project procedures, project management activities as appropriate.Plan Commissioning & Qualification activities and tracknexecution of C&Q activities/documentation versus project timeline. Write/review C&Q plans, study/test protocols, and summarynreports.  Manage execution of study/test protocols and review testnresults. Commissioning and qualification protocol execution, and managenprotocol deviations, investigation and corrective action activities Have excellent analytical skills with systematic approaches tonproblem solving. Demonstrate ability to comprehend mechanical/electrical drawingsnand related engineering prints for C&Q activities.The position requires a combinationnof sedentary work and walking around the cGMP manufacturing facility

Job Tagsn

Working knowledge of cGMP guidelines, FDA 21 CFR Partn820/210/211, ICH guidelines and other international regulatory requirements.

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