Validation Specialist

• Jul 2022 - Present

Engineer II (Validation)

• Jan 2022 - Jul 2022

Engineer I (Validation)

• Apr 2020 - Jan 2022

Co-Op

• May 2019 - Apr 2020

•Performed commissioning IQ, OQ, PQ activities for process equipment and utilities including protocol preparation, scheduling, protocol execution, data analysis and authoring final reports. •Authored and executed requalification for controlled temperature chambers, and incubators. •Responsible for analyzing batch records in support of annual Product Quality Review. •Conducted room inspections in various areas including airlocks, cell culture rooms, and recovery suites. •Received theory based training on quality cGMP practices, gowning and personnel flow from various areas in manufacturing.•Technical review of summary reports written for autoclaves, cold rooms, controlled temperature chambers, and bioreactors. •Performed Riboflavin testing on various pieces of equipment including bioreactors and process vessels. •Supported SIP (Steam in Place) testing on a variety of Bioreactors.•Authored Hardware Design Specifications and Manuals for portable vessels and other process equipment. •Draft, edit, and review Standard Operating Procedures and Work Instructions. •Supported the harmonization of equipment sampling plans to include swab area information, and correction factors. •Performed spray sterilization on various materials with the use of a Steramist device. •Assisted in editing User Requirement Specifications for various pieces of equipment. •Executed thermal mapping on freezers, incubators, and cold rooms by collecting data using a Kaye Validator or Data Loggers, placing them in proper locations, and creating reports based on the data.•Utilize Microsoft Excel for organization of various pieces of data including equipment lists, and tracking of batch records to perform trending analysis using JMP system. •Authored Cleaning Validation documents including Master Plans, Protocols, and Summary Reports. •Analyzed samples recorded into LIMS (Laboratory Information Management System) during the execution of Cleaning Validation Protocols Show less

Lead Pharmacy Technician

• Apr 2011 - Jul 2019

• Execute Standard Operating Procedures on a daily basis. • Provide training for new hires and associates in need of extra assistance. • Collaborate with associates to complete daily, weekly, and monthly checklists. • Organize monthly wellness events to provide free health care checks to the community. • Create a weekly schedule for pharmacy staff that provides daily optimal workflow. • Resolve insurance rejections and provided solutions in a timely manner. • Communicate effectively with health care providers to ensure patient safety. Show less