Staff Engineer
Current• Develop and execute cGMP documentation and test protocols for validation, qualification, and decommissioning of benchtop laboratory equipment (thermal validation systems, particle counters, cell viability analyzers, plate washers, plate readers, liquid handlers)• Develop system lifecycle documentation (quality assurance plans, requirements/configuration specifications, installation/operational qualification test protocols, summary reports) supporting the deployment of new/upgraded automation systems and manufacturing process equipment• Develop change management documentation / project change controls for automation systems in a pharmaceutical manufacturing environment, including leading design reviews, initiating change proposals, performing impact assessments, and assigning/executing change implementation tasks• Support plant operations by performing recipe/parameter changes and alarm troubleshooting on sterile supply equipment, including hands-on cycle development work with autoclaves and parts washers in a clean room environment• Use AssetCentre software to manage PLCs, HMIs, equipment configurations, and audit trail information• Perform security vulnerability remediation on automation servers