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Paul Valerio

Director, Technology

Sterile Expert

Areas of Expertise

  • Advanced Aseptic Design
  • OSD Processes
  • Design for Potent Compounds
  • Vendor Management
  • Risk Assessment & Mitigation
  • Technical Consultancy
  • Failure Modes & Effects Analysis (FMEA)
  • Root Cause Analysis

 

New products and ever improving quality drive the pharmaceutical industry forward and present steady challenges for drug manufacturers. I enjoy working with clients to determine appropriate process technologies and implement them in a robust manner, as well as supporting them to work through difficult operational challenges.

- Paul Valerio
Director, Technology

Paul is a leading expert in the application of engineering methods, Six Sigma tools and Quality Risk Management to design, implement and optimize advanced aseptic systems, OSD processes and containment technology.

Paul’s diverse and highly valued skillset has been developed over a 20 year career working in various roles for a rare combination of multinational pharmaceutical corporations, a leading containment equipment manufacturer, and now a well-established architectural, engineering and construction 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’s work has resulted in patents, co-authoring, as well as presenting at industry events.  Recent engagements include:

“Facing Your Challenges without a Black Belt: Solve Problems and Achieve Consensus with Simple, Well Applied Tools” – ISPE Annual Meeting, November 2014

"Six Sigma is Not Just for Black Belts" - Interphex New York, March 2014.

"Critical Elements for Implementing Advanced Aseptic Technology", Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2014, March 2014, pp 6-8.

  • p. 888.366.7660

Recent Projects

  • Aseptic Vial Filling and Lyophilization Line with Isolator Technology
  • Tech Transfer Risk Assessment for a Lyophilized Product
  • OSD Atypical Visual Particle Risk Assessment
  • Facility Design & Vendor Management for a Vial Filling Upgrade with RABS Technology.
  • Process Equipment URS Development for a Potent Compound OSD Facility
  • Facility Design and Integration of Multi-format, Isolated Aseptic Filling/Lyophilization Line