Bruce Klopfenstein

Bruce has over 30 years of experience as a program, project, engineering, and commissioning & qualification manager for medical device, biotechnology, pharmaceutical, and manufacturing organizations. His hands-on experience includes managing engineering and maintenance departments for pharmaceutical/medical device manufactures. Bruce also develops and manages efforts for plant and corporate quality systems, validation master plans, software validation, compliance strategies including ASTM Risk-Based and ISPE baseline, commissioning plans, construction turnover, change controls and protocol development and execution. Bruce’s automation experience includes programming PLC’s, DCS’s and SCADA systems.