Permanent or contract Validation Engineer.
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I have been in Pharmeceutical Manufacturing for over 20 years.
Most recently I have been a contract Validation Engineer.
Twenty years of experience in the highly-regulated cGMP/cGLP Pharmaceutical and Medical Device industries. Experience includes several years of Production Management at various pharmaceutical manufacturers, writing SOPs, deviations, non-conformance reports, and hands-on supervision and training of technicians. All the while learning and implementing cGMP, cGDP, to meet FDA regulations, as well as ISO, OSHA, and EU standards.
Went on to become a Quality Engineer in QA roles such as Technical Writing, batch record review, and deviation, NCR, OOS investigations, Root Cause Analysis, and close-outs. Mastered the writing, execution, and summarizing of equipment commissioning, IQs/OQ/PQs and cleaning protocols, as well as Validation Master Plans, as a Sr. Validation Engineer. Well versed in QA, QC, Project Management, GMP compounding and packaging of solids, oral liquids, and sterile injectables.
An expert in Microsoft Office and well-rehearsed with many types of software including MS-Project, LIMS, SharePoint, TrackWise, AutoCAD, SolidWorks, and Visio. A team player, highly motivated, and also works well independently to achieve project goals. Always well organized.
BS in Biochemistry from SUNY Stony Brook.
