TJ has 32 years of experience working in nearly all aspects of FDA regulated industries. Since 2003 he has been exclusive to validation and in that time has become a subject matter expert on steam sterilization, depyrogenation, and controlled temperature chamber validation. He has provided commissioning, validation, and process optimization services to clients internationally in the pharmaceutical, biotechnology, tissue banking, blood plasma, cell therapy, and medical device industries.

Having spent the early part of his career in process development and manufacturing roles, he has specific experience in large and small-scale production processes as well as a wide array of equipment-related validation experience in upstream and downstream processing equipment, chemical sterilizers, utilities, CIP and SIP cycles and processes, aseptic filling, terminal sterilization, and deviation investigations.

TJ also holds a PMP certification from the Project Management Institute and has managed large and small projects at numerous pharma companies as well as remaining a validation practitioner.

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Our Trainers are Certified by PMI, Six Sigma, and The American Society for Quality Training

PMP PMI certified project manager
ASQ software division member
six sigma certified project manager