Experience

Cook MyoSite

• United States
• Biotechnology Research
• 100 - 200 Employee

• Validation Engineer

  • Mar 2014 - Jul 2018

  —Maintained the validated state of a cGMP clinical manufacturing and research facility by coordinating with end-users and development scientists to ensure impact assessment (IA), commissioning, and qualification activities documented the capability of all systems to support identified critical process parameters (CPA) and critical quality attributes (CQA). —Authored and executed validation and verification (V&V) protocols and summary reports (SR) for facilities, systems, equipment (FSE)… Show more —Maintained the validated state of a cGMP clinical manufacturing and research facility by coordinating with end-users and development scientists to ensure impact assessment (IA), commissioning, and qualification activities documented the capability of all systems to support identified critical process parameters (CPA) and critical quality attributes (CQA). —Authored and executed validation and verification (V&V) protocols and summary reports (SR) for facilities, systems, equipment (FSE) including analytical instruments (AIQ) for enrolled systems as required. Equipment included a SKAN PSI-M w/ SARA sterility testing isolator —Developed supporting documentation including standard operating procedure (SOP), work instruction (WI), forms, and templates including IAs, user requirements specification (URS), enhanced design review (EDS), criticality assessment (CA), calibration, maintenance, and other lifecycle requirements per regulatory and industry guidances. —Authored Quality System (QS) deviation investigations and protocol exception reports (PER), change requests (CR) and controls, corrective action/corrective actions (CAPA) recommendations. —Trained and qualified personnel on validation-related activities, cleanroom gowning, and aseptic media fills as needed.

• Production Associate

  • Nov 2012 - Mar 2014

  —Accomplished aseptic manufacture of clinical trial of autologous clinical cell therapy per batch record instruction in a cGMP cleanroom, including biopsy dissociation, medium replacement, passage, harvest and cryopreservation, and formulation and fill. —Authored root cause analysis (RCA) investigations to assess product SISPQ impact.

• Production Assistant

  • May 2012 - Nov 2012

  —Accomplished pre-process, in-process, and change-over activities for cGMP clinical cell culture inside ISO 5, ISO 7, and ISO 8 environments, including manual and automated confluence, flow cytometry, and batch record documentation. —Authored root-cause analysis deviation investigations relating to assess impact to product and materials and determine appropriate CAPA corrections to the Quality System.



PITTSBURGH TISSUE ENGINEERING INITIATIVE, INC.

• Biotechnology Research

• Summer Intern

  • Jun 2009 - Aug 2009

  —Engaged in intensive intern experience focused on ELISA immunoassays, cell culture, data analysis, data presentation, and bioethics within the Ferguson Laboratory for Orthopaedic & Spine Research at the University of Pittsburgh. —Engaged in intensive intern experience focused on ELISA immunoassays, cell culture, data analysis, data presentation, and bioethics within the Ferguson Laboratory for Orthopaedic & Spine Research at the University of Pittsburgh.