Experience

MacroGenics, Inc.

• United States
• Biotechnology Research
• 200 - 300 Employee

• Validation Manager

  • Jan 2022 - Present

• Senior Validation Specialist

  • Jan 2020 - Jan 2022

• Validation Specialist III

  • Aug 2017 - Jan 2020

• Validation Specialist II

  • Sep 2014 - Aug 2017



Cangene bioPharma

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Validation Specialist II

  • Jan 2013 - Sep 2014

  •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… Show more •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. Show less •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… Show more •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. Show less



QIAGEN

• Netherlands
• Biotechnology Research
• 700 & Above Employee

• Validation Specialist II

  • Sep 2008 - Dec 2011

  •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… Show more •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. Show less •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… Show more •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. Show less



BioReliance

• United States
• Biotechnology Research
• 400 - 500 Employee

• Validation Specialist

  • Apr 2006 - Sep 2008

  •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… Show more •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. Show less •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… Show more •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. Show less