Results oriented project management professional with over 25 years of diversified experience in the engineering, procurement, construction, commissioning, qualification, operation, project management, technology transfer and quality management systems of regulated cGMP pharmaceutical, biotech, and medical device manufacturing facilities, systems and equipment. Innovative thought leader with excellent communication and interpersonal skills needed to drive and deliver complex projects across large cross-functional, matrixed organizations. Provides immediate value to projects, programs and operations by employing good engineering practices, good manufacturing practices, science and risk-based approaches, lean methodologies and years of lessons learned to minimize risk, accelerate project timelines and provide significant cost savings. Subject Matter Expert and team leader delivering upon the project management and engineering lifecycle associated with implementing single-use bioprocess cleanroom facilities, systems, equipment and associated engineering and quality systems documentation. Purveyor of the ISPE baseline and guidance documents for delivery of capital projects for sterile biopharmaceutical facilities, systems and equipment, CQV, CSV, SUT, GMP operations and quality risk management. ISPE Member Since 1999.Expertise → Capital project delivery → Specification and procurement of bioprocess equipment → Commissioning, Qualification and Validation → Quality Management Systems → Aseptic processing → Single-use technology → Upstream and downstream bioprocess operations → Media and buffer preparation and hold → CIP/SIP → FDA, EMA, GxP, ICH, USP, PIC/S compliance