Validation Specialist IQ/OQ/PQ

JOB REQUIREMENTS: Prepare detailed reports or design statements, based

on results of validation and qualification tests or reviews of procedures and protocols. Maintain validation test equipment. Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards. Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for production of pharmaceuticals, electronics, or other products. Resolve testing problems by modifying testing methods or revising test objectives and standards. Draw samples of raw materials, intermediate products, or finished products for validation testing. Direct validation activities, such as protocol creation or testing. \*\** OTHER EXPERIENCE AND QUALIFICATIONS: Hands-on experience executing IQ, OQ, and PQ validations in a manufacturing environment required Strong working knowledge of ISO standards relevant to medical device manufacturing (ISO 13485, ISO 9001, or similar) Experience operating and qualifying manufacturing equipment (assembly, sealing, printing, dispensing, or similar) Exceptional attention to detail particularly in documentation, data recording, and protocol execution Proven ability to create and manage validation documentation that meets regulatory and quality system requirements Strong organizational and scheduling skills able to coordinate validation activities around active production schedules Ability to work independently and manage multiple validation tasks simultaneously \*\** APPLICATION INSTRUCTIONS: E-Mail a Rsum: View email address on jobs.institutedata.com