Senior Validation Engineer
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Graduate of a Master of Science in Engineering Management. A goal driven Packaging Development Engineer/Validation Engineer with 6+ years of experience in project management, designing, consumer goods and pharmaceutical industry. Experienced in developing and implementing package component specifications and testing protocols for various products leading to successful product launches.
Worked closely with a multidisciplinary team to address issues identified in mock audits by conducting thorough analysis and implementing effective solutions. Have experience with various equipment used in zip-dose production and ensure compliance with FDA regulations; collaborate cross-functionally with different departments to support operations, regulatory requirements, and risk management. Responsible for validation processes, including documenting commissioning activities and performing qualification studies to ensure consistent production of high-quality drug products.
I have also handled project development for sustaining engineering activities and performed statistical analysis on production line trials and qualifications.
Compliance gaps is remedied, and computer system validation deliverables are developed and reviewed. I have worked closely with senior leads, equipment vendors, and operation personnel for equipment validation and performed various activities related to packaging and assembly/labeling. Also engaged in quality control inspections, labeling revisions, and compliance with ISO and FDA regulations.
Masters in Engineering Management.
