Andrew Walsh

Email: [email protected]
School:  Schaefer School of Engineering & Science
Department:  Mechanical Engineering
Program:  Pharmaceutical Manufacturing Engineering
  • M.S., Biology, Fairleigh Dickinson University, 1982
  • B.S., Biology, Fairleigh Dickinson University, 1976

Stevens Pharmaceutical Research Center (SPRC)

Professor Walsh founded SPRC in the summer of 2009 with 1 full time and 2 part time Research Assistants working on Total Organic Carbon Analysis and Visual Inspection for Cleaning Validation and developing lab practicals for PME courses. Additional areas of research have been added since, including the PAT application of TOC in CIP systems and automation of electronic GMP systems. SPRC has grown quickly to more than 50 ongoing projects, which resulted in 12 posters presented at the 1st Annual SPRC Poster Show on June 15, 2011. 6 of these posters were entered into the NJ-ISPE Student Poster Competition and 1 poster won Best Stevens Graduate Poster. SPRC also presented posters at the Stevens Graduate Research Conference in 2009 (1 poster), 2010 (2 posters) and 2011 (4 posters). SPRC's research efforts are supported by a number of corporate donors including General Electric (Sievers), Waters-ERA, Ecolabs, Texwipe, Alconox, Testos, Glaxo Smith Kline and Bristol-Myers Squibb. In addition, funded research has been provided from AMCOL Health and Beauty Aids, C.R. Bard, and Waters-ERA.

  • Over 20 years of Pharmaceutical Industry in Validation at three Johnson & Johnson companies, Schering-Plough and Hoffmann-La Roche.
  • Training and Consulting to the Pharmaceutical Industry on application of Lean and Six Sigma principles to Cleaning Process Development and Validation since 2007 (Clean6Sigma, LLC) 

Andrew is an Industry Professor in the Pharmaceutical Manufacturing and Engineering Graduate Program and teaches courses in Pharmaceutical Validation and Lean Six Sigma. Andrew is a certified Lean Six Sigma Black Belt and an Accredited Training Associate through the International Association of Six Sigma Certification.

Andrew has over 20 years of "hands-on" Validation experience working in the Pharmaceutical Industry in Equipment and Utility Qualification, Process Validation, Cleaning Validation, Analytical Method Validation, Spreadsheet Validation and Computer Systems Validation. Prior to working in the Pharmaceutical Industry, Andrew had 10 years of prior experience working as an Analytical Chemist and Microbiologist with the Colgate-Palmolive and Clorox companies.

Andrew is also Principal and Owner of PharmaClean Group, LLC a consulting and contracting firm providing consulting, contract services, laboratory services, on-line and on-site training, equipment maintenance services and products for Cleaning Process Development and Cleaning Validation.  PharmaClean Group uses the application of their trademarked Clean6Sigma® approach for using statistics and risk assessment to developing and evaluating cleaning processes. Andy has provided training and consulting to large and small pharmaceutical companies including Actavis, Bristol-Meyers Squibb, C.R. Bard, Genentech, Johnson and Johnson, Novartis, Rhodes Technologies and Takeda Pharmaceutical.


Institutional Service
Advisor to the Stevens Pharmaceutical Research Center (SPRC) Graduate Club.
Professional Service
  • Team Member and author of ISPE’s Risk-based Manufacture of Pharmaceutical Products Guideline (Risk-MaPP)- published Fall 2010
  • Team Leader and principle author of ISPE’s Science and Risk-based Cleaning and Cleaning Validation Guideline - in progress
  • Team Leader and principle author of ASTM’s Cleaning Development and Cleaning Validation Standard - in progress
  • NJ-ISPE Board of Directors 2008-2011
Consulting Service

Provides consulting services to the Pharmaceutical Industry through Clean6Sigma, LLC (www.clean6sigma.com) and through the Stevens Pharmaceutical Research Center in Cleaning Process Development, Cleaning Validation Method Development and Total Organic Carbon Analysis

Honors & Awards
Winner of ISPE Committee of the Year for 2010 - Risk-MaPP (Risk-based Manufacture of Pharmaceutical Products) Task Team Member
Professional Societies
International Society of Pharmaceutical Engineers
American Society for Testing and Materials
American Society for Quality
Regulatory Affairs Professionals Society
Selected Publications
  1. Walsh, A., M. Ovais, T. Altmann, E.V. Sargent. (Nov 2013). "Cleaning Validation for the 21st Century: Acceptance Limits for Cleaning Agents", Pharmaceutical Engineering, 31 (5),  Download  (772 kb PDF).
  2. Walsh, Andrew. (2011). "Cleaning Validation for the 21st Century: Overview of the New ISPE Cleaning Guide", Pharmaceutical Engineering, November/December 2011. Vol. 31 (No. 6),  Download  (470 kb PDF).
  3. Walsh, Andrew. (2011). "Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part II", Pharmaceutical Engineering, September/October 2011. Vol. 31 (No. 5),  Download  (1514 kb PDF).
  4. Walsh, Andrew. (2011). "Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part I", Pharmaceutical Engineering, July/August 2011. Vol. 31 (No. 4),  Download  (1174 kb PDF).
Book Chapters
  1. Andrew Walsh. (2011). "Microbial Aspects in Cleaning Validation", Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices , Madhu Raju Saghee, Tim Sandle and Edward C. Tidswell, Business Horizons.
Conference Proceedings
  1. Andrew Walsh. "Leader of “Cleaning for the 21st Century” Program", International Society of Pharmaceutical Engineers Conference Washington D.C. June 2008.
  2. Andrew Walsh. "Co-Leader of ISPE Risk-MaPP Program", International Society of Pharmaceutical Engineers Conference Washington D.C. June 2007.
  • PME 530 Introduction to Pharmaceutical Manufacturing
  • PME 540 Validation in Pharmaceutical Manufacturing
  • PME 541 Validation of Computerized Systems
  • PME 555 Lean Six Sigma
  • PME 640 Contemporary Concepts in Pharmaceutical Validation
  • PME 800 Specical Problems in Pharmaceuticals Manufacturing and Engineering