Sr. Engineer, Sterility Assurance

• Jan 2020 - Present

Sterility Assurance Assocaite II

• Apr 2014 - Jan 2020

• Responsible for development, execution, planning, and reporting Sterility Assurance process validations and routine maintenance activities, including: environmental monitoring programs for cleanrooms, sterilization by radiation, sterilization by ethylene oxide, bioburden and sterility test methods, disinfectant efficacy, steam sterilization (autoclaves), and depyrogenation by dry heat• Member of numerous project teams and currently responsible for determining/documenting sterilization impact for proposed product changes• Act as Sterility Assurance subject matter expert for third party audits• Responsible for generating, revising, and providing Sterility Assurance input on company standard operating procedures• Familiar with Sterility Assurance industry guidance documents and standards for tissue and medical devices• Assist in maintenance of Sterility Assurance budget Show less

Sterility Assurance Engineer I

• Apr 2013 - Apr 2014

• Utilized a basic understanding of Sterility Assurance principles to perform routine maintenance activities, including: autoclave and depyrogenation oven requalifications, radiation dose audits, ethylene oxide requalifications, and controlled environment qualifications

Temporary Pilot Production Lab Technician

• Aug 2012 - Apr 2013

• Pilot production lab technician responsible for preparation of a hemostatic medical device in accordance with cGMP guidelines• Accountable for maintaining a clean laboratory environment and ordering laboratory supplies • Thoroughly documented all production processes following strict methodologies and Good Documentation Practices