Manufacturing Specialist
CurrentDeviation Investigation/Reporting (Trackwise) AKTA Unicorn Method AuthoringIQ/OQ/PQ Validation Document Authoring/Execution Master Batch Record AuthoringLIMS Sample Management SoftwareProcess/Technical Transfer ExperienceDocument Change Requests Equipment OnboardingSite Acceptance Testing (SAT) Master Equipment File Creation ARIBA Equipment Procurement Mammalian/Microbial Downstream Processing• Subject Matter Expert (SME) for AKTA Process skids. Worked with the vendor to establish PM intervals & elastomer change-outs, Authored and Executed IOV documentation, created column testing (HETP), column sanitization and storage, and mammalian/microbial chromatography process methods coded in the Unicorn Software suite.• Experienced with Technical Transfer. Authored 25+ Solution batch records coordinating with Process Development and utilizing Facility Fit Reports and Process descriptions/summaries.• SOP creation and editing. Authored new SOP’s for the AKTA process skid, Spectrophotometer and pH meters.• Multiple successful facility start-ups, Microbial (February 2015) and mammalian (January 2016)