Mr. Roy offers more than 30 years of dedicated professional experience in all phases of advanced aseptic processing, including engineering, quality, qualification and manufacturing operations for the pharmaceutical and biotechnology industries.  He has particular technical expertise in barrier isolation technology, potent material handling and containment, cleaning validation and CIP/SIP systems.

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He has served in senior level management roles directing global engineering, design and manufacturing teams on fast-track design/build/qualification activities for clinical and commercial scale aseptic fill/finish facilities.  He co-developed a flexible isolator configuration which allowed isolated formulation and fill/finish operations within a single isolator.  Mr. Roy has developed quality and qualification documentation for cleaning, environmental and clean utility monitoring and equipment and process validation programs for sterile manufacturing operations worldwide.

 

Considered a subject matter expert in the engineering, qualification and application of advanced aseptic technology, Mr. Roy is a welcomed speaker at association meetings and conferences, and has given numerous presentations and written in many publications . He is a member of ISPE and has lectured frequently. Rob is a well respected figure in the aseptic community and has successfully completed a wide variety of projects ranging from R&D to clinical manufacturing to manufacturing facilities for potent compounds and sterile products utilizing vials and syringes.  He is also experienced with the integration of single-use technology for formulation and fill/finish activities.

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