Expert in GMP and GDP exercising oversight of the validation of systems utilized in biopharmaceutical manufacturing including: o Equipment (Bioreactors, Chromatography systems) o Automation (Delta V, Control systems) o Utility systems (WFI, HVAC) · Review and approval of validation master / executed protocols and final reports · Review and approval of deviations for validation protocols · Rev...
Gaithersburg, Maryland, United StatesI support management of qualification of manufacturing and lab equipment, facilities, utilities and shipping in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. Responsibilities include but are not limited to: • Serves as a technical resource or subject matter expert on methods and techniques within Validation. ...
Gaithersburg, Maryland, United StatesAs a Senior Validation Specialist at Novavax, I have managed several projects involving the initial set up of pharmaceutical manufacturing and Quality Laboratories involving the qualification of analytical equipment, facilities and shipping to GMP and FDA CFT Part 11 compliant standards. I have worked as and mentored other project managers in the process of moving entire laboratory department...