•Tested DataAnalyst, PharmaceuticalNet, CISPro, and TrackWise software systems.•Lead all validation efforts related to testing and compliance of drug labeling equipment, barcoding, and computerized systems.•Prepared and executed cleaning disinfectant studies.•Participated in project reviews through the use of FMEA based risk analysis and risk management.•Lead the life cycle approach for the new packaging room expansion to include vendor quote submittals, validation plans, DQ’s, RA’s, FAT’s, commissioning, protocol generation (IQ, OQ, PQ), and execution.

•Gathered, analyzed, and evaluated information from a variety of client and manufacturing resources.•Prepared comprehensive written reports and presentations based on tested and collected data.•Detected and identified deviations and errors during the manufacturing process.•Provided statistical sampling plans for proper validation of manufactured product.•Performed training for management and personnel on key standard operating procedures.•Continually analyzed work processes and recommended ways to improve operations and testing methods.•Identified and interpreted raw material specifications, production processes, and quality control to maximize effective manufacturing and validation testing.•Provided guidance and expert advice to management and departments on technical and process related topics.•Created and revised standard operating procedures for change control, preventive maintenance, and validation.

•Interacted with computer interfaces to set up equipment functions, data, and process information.•Reviewed and identified information in procedures and validation protocols by recognizing differences or similarities of drafted and completed testing. •Designed and created procedures, applications and testing methodologies to streamline the validation process. •Communicated with clients for problem solving of defective and disabled equipment. •Developed specific goals and plans in order to organize multiple validation projects and meet deadlines.•Estimated time, costs, quantities, resources, and materials required to perform accurate testing.•Created and revised documents such as protocols, standard operating procedures, system risk assessments, user requirements specifications, validation plans and reports, and revalidation assessments.•Assisted in training of personnel on revised standard operating procedures.