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Dan Klees


Principal Biotech Consulting Engineer

A true industry opinion leader, Dan Klees brings 40+ years’ experience to the Agilitech team, with extensive knowledge of biopharmaceutical unit operations, process equipment, process instrumentation, cGMP, metrology, validation/qualification, root cause analysis, feed-back and feed-forward control, as well as non-linear, adaptive, and digital blending control.

Dan has held executive positions in engineering and executive management with biopharmaceutical integration and engineering firms as well as senior operations and management positions with major biopharmaceutical automation and process instrumentation companies. He is the founder of the consulting company, Critical Approach, LLC, a biopharmaceutical consulting services company.

He served 14 years as the founding chairman of ASME BPE Process Instrumentation Subcommittee and holds nine U.S. and European patents related to hygienic process measurement, single-use and disposable instrumentation, and instrument calibration methods.

Dan has been formally trained as a certified cGMP Instructor and has developed and conducted many training courses on cGMP basics, validation and qualification, Process Analytical Technology (PAT), and Corrective and Preventative Actions (CAPA). He has also developed factory audit checklists and conducted factory audits of instrumentation companies.

Dan has published several automation and advanced control algorithm articles in leading technical journals, published articles on single-use disposable systems and has presented numerous papers and seminars at international biopharmaceutical symposia. He has also been a graduate school guest lecturer on process automation and control theory at several universities.

Professional Affiliations:

  • Served 14 years as Founding Chairman of ASME BPE Process Instrumentation Subcommittee
  • Voting member ASME BPE Standards Committee
Education, Strengths, Technical Skill Sets:

  • Master of Science, Physics, Miami University
  • ASME BPE subject matter expert on process instrumentation
  • Extensive knowledge of biopharmaceutical unit operations, equipment, process instrumentation, metrology, preventative maintenance, cGMP regulations, and validation
  • Extensive expertise in root cause analysis, addressing of FDA Form 483, and CAPA plans
  • Professionally trained, highly qualified instructor and teacher.
  • Project management
  • Engineering management
  • Collaborating with clients, associates, and external contacts.