Performance Validation
Company Employees
Rebecca Hawkins
Principal CQV Consultant @RCHawkins Engineering
Verified
Experienced in providing technical management and validation services to the medical device, biologics, and pharmaceutical industries. Team player, who works well with management, engineering, Quality, and production personnel. Strong teamwork ability and strategic resource planning for tight timeline delivery. Strong understanding of the basics in process equipment design including piping and instrumentation, pumps, valves, filters, etc. Strong written and oral communication skills. Technical Managment Project Management Capital Projects Commissioning & Qualification Process Validation Facilities, Utilities, Systems, Equipment (FUSE) Software Validation/CSV Automation - Rockwell PLCs SCADA, DCS, PCS, BMS Bespoke code Bespoke equipment Remediation (483) CAPA Change Management Risk Management cGMP HVAC Clean Utilities Aseptic Fill/Finish Parenterals Oral Solid Dosage Biologics Cell/Gene Therapy Medical Devices Injection Molding Extrusion Packaging Serialization / Aggregation Supply Chain Sterilization Temperature Mapping Risk-Based Validation Quality by Design (QbD) PFMEA/DFMEA MS Project Minitab DeltaV Trackwise Maximo CMMS Kneat Siemens S7 ISO USP 21 CFR 210, 211, 820 21 CFR Part 11 GAMP5More...