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Paul F. Valerio

Director, Process Technology

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"Many manufacturers have their heads down hard at work manufacturing with older technologies. One of my most important roles is helping them understand and then implement the many recent advances in aseptic process technology."

Paul’s diverse and highly valued skill set has developed over a two-decade career working in various roles for a rare combination of multinational pharmaceutical corporations, a leading containment equipment manufacturer, and now a well-established technical consulting, design, engineering, construction, project controls, commissioning and qualification firm. A combination of strong technical ability, business acumen, interpersonal skills, and international experience make him a solid asset for the clients he supports.

Paul brings his skills and experience to support clients manufacturing sterile products in multiple dosage forms, both liquid and lyophilized, through all stages of design and manufacturing, including master planning through detailed design phases, URS development, vendor management and FAT support, and technical transfer analysis.

  • B.S. - Mechanical Engineering, Lehigh University
  • M.S. - Applied Mechanics, Lehigh University
  • International Society for Pharmaceutical Engineering (ISPE)
  • Merck & Co.
  • Bristol-Myers Squibb
  • Valerio, Paul, et al. "2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology." Pharmaceutical Engineering Magazine, July-August 2020.
  • Valerio, Paul. “Leapfrog: An Opportunity for Sterile and OSD Product Manufacturers with Aging Facilities to Minimize Containment Exposure, Reduce Risk, and Become More Profitable.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2018 Supplement, 18 April 2018.
  • Valerio, Paul. “Leapfrog: An Opportunity for Sterile Product Manufacturers with Aging Facilities to Reduce Risk and Become More Profitable.” INTERPHEXblog.com, 30 March 2018.
  • Valerio, Paul. “Innovative Technologies Roundtable.” Pharma’s Almanac, 26 October 2017.
  • Valerio, Paul. “A Vision for Full Scale, Isolator-Based Aseptic Filling Systems.” INTERPHEXblog.com, 10 February 2017.
  • Valerio, Paul. “Designing for Potent Compound Exposure Levels - Not as Easy as 1-2-3.” Pharmaceutical Processing, 25 March 2015.
  • Valerio, Paul, et al. “Looking for a Challenge? Try Designing a Flexible Potent Compound Multi-Product Generic OSD Plant.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2015 Supplement, pp. 20-22, 1 March 2015.
  • Valerio, Paul, et al. “Designing Aseptic Facilities Amid Changing Business Drivers and Technologies.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2015 Supplement, pp. 4-6, March 2015.
  • Valerio, Paul. “The Flexible Filling Line: The Crossover Vehicle for Aseptic Manufacturing.” INTERPHEXblog.com, 10 December 2014.
  • Valerio, Paul, and Jerrod Shook. “Critical Elements for Implementing Advanced Aseptic Technology.” Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2014 Supplement, pp. 6-8, 1 February 2014.
  • Valerio, Paul. "Use of Robotics in Aseptic Processing: Lessons Learned, ISPE Aseptic Conference, 18 March 2019, North Bethesda, MD.
  • Valerio, Paul. “Settling the Frontier of Fill-Finish Operations – High Tech Filling in a Proper Abode.” INTERPHEX, April 2018, New York City, NY.
  • Valerio, Paul. “Trends in Aseptic Filling Technology – the Future is Here!” 2016 ISPE UK Affiliate Annual Conference, 10 November 2016, Leeds, England.
  • Valerio, Paul. “Facing Your Challenges without a Black Belt: Solve Problems and Achieve Consensus with Simple, Well Applied Tools.” ISPE Annual Meeting & Expo, October 2014, Las Vegas, NV.
  • Valerio, Paul. "Six Sigma is Not Just for Black Belts." INTERPHEX, March 2014, New York City, NY.

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