Experience That Moves Projects Forward
Representative experience includes leadership and hands-on execution across pharmaceutical and biotechnology engineering, CQV, quality, manufacturing, automation, and capital projects.
Biotechnology Facility Design & Project Execution
Led multidisciplinary engineering/scientific teams supporting facility and process design, project execution, construction initiation, equipment installation, startup, and turnover.
CQV & Validation Execution
Executed and led commissioning, qualification, and validation activities for pharmaceutical manufacturing equipment and systems, including protocol development, execution, discrepancy resolution, and turnover.
Isolator Qualification & VHP Cycle Development
CQV and QA support for isolator and aseptic processing systems, including qualification, VHP cycle development, and validation execution.
Clean & Black Utility Qualification
CQV/QA support for clean and black utility systems, including development and execution of commissioning and qualification documentation, system verification, discrepancy resolution, and turnover.
Manufacturing & Process Improvement
Led manufacturing investigations, root-cause analysis, corrective actions, equipment upgrades, process improvements, and operator development, including initiatives that significantly improved operational performance.
Process Scale Up & Technology Transfer
Led process development and scale-up, technology transfer, and large-scale fermentation activities, including implementation of manufacturing processes and support of PLC/SCADA-based automated systems.
Experience Across Complex Manufacturing Environments
From process equipment and utilities to automation and manufacturing operations, QBS brings practical experience across the systems and disciplines required to execute regulated projects successfully.
Process & Manufacturing Systems
Fermentation, process equipment, manufacturing systems, equipment installation, startup, troubleshooting, and process optimization.
Facilities & Utilities
Clean utilities, black utilities, facility systems, equipment infrastructure, commissioning, qualification, startup, and operational readiness.
Automation & Controls
PLC/SCADA systems, automated manufacturing equipment, CSV support, system implementation, troubleshooting, and integration.
Quality & Validation
CQV, QA support, validation, GMP documentation, investigations, change control, risk assessments, and qualification documentation.
Need Experienced Support for Your Next Project?
QBS provides experienced technical professionals who can integrate with your team and support projects from planning and execution through qualification, startup, and operation.