Editorial Team

Editorial Staff


Sr. Director, Global Communications, Anna Maria di Giorgio
Publications Manager, PE Magazine, Amy Loerch


  • Diane Munda, Sales Coordinator
    Tel: +1-813-960-2105 Extension: 399
  • Robin Lane, Sales Coordinator
    Tel: +1-813-960-2105 Extension: 235

ISPE Pharmaceutical Engineering Committee

Chair, Roger Nosal, Pfizer Inc.
Jane Brown, GlaxoSmithKline (Retired)
Stephen Bryan, AstraZeneca
Nissan Cohen, Rohrback Cosaco Systems Inc.
Rajesh V. Dave, Bristol-Myers Squibb
Michelle M. Gonzalez, PE, BioPharm Engineering Consultant
Michael R. Goodman, Compliance-Insight
Wendy T. Haines, PhD, Mangan Inc.
Jeff Hargroves, ProPharma Group Inc.
Jennifer Lauria Clark, CPIP, Commissioning Agents, Inc.
Catherine E. Middelberg, Pfizer
Louis L. Milano, Project Planning & Development LLC
James M. O'Brien, NAMA Industries Inc.
Mark A. O'Donnell, Azzur Group, LLC
Jeffery N. Odum, CPIP, IPS
Panagiotis A. Papadopoulos, Villanova University
Mary S. Poor, Clinipace Worldwide
Tony Rao, Stantec Consulting Services, Inc.
Judy Samardelis, MedImmune
Terry J. Seanard, Jr.,CPIP, New England Controls, Inc.
Pravin K. Todkar, Siemens Ltd.
Steven J. Wisniewski, Commissioning Agents, Inc.
Vijay Yadav, InVentiv Health
Joerg Zimmermann, Vetter Pharma Fertigung GmbH

Editorial Reviewers Board

Nuha Al-Hafez, Teva
Asa Ahlqvist, McNeil
Praveen Bezawada-Joseph, Fisher BioServices
Purusottom Bhattacharjee, Fresenius kabi Oncology
Rory Budihandojo, Boehringer Ingelheim Pharma
Jose A. Caraballo, Bayer
John T. Connor, Sales and Marketing Consultation
Steven C. Davy, NNE Pharmaplan
Robert Del Ciello, PE, Northshire Associates
Dr. Thomas C. Dine, Dine Consultancy Ltd.
Martin Martin Düblin, 11 Eleven GmbH
Ronald C. Gaughf, Eli Lilly & Co. (retired)
Mervyn L. Hamer, Novavax
Vijay Kasireddy, CPIP, Alexion Pharmaceuticals Inc.
Willem Kools, EMD Millipore
Dr. Wei Liu, Genentech Inc.
Orlando Lopez, Allergan Inc.
Joseph J. Manfredi, GMP Systems, Inc.
Allan Marinelli, Quality Validation 360 Inc.
Paul A. Melamud, QPharma
Dr. Jakub Mocny, CPIP, Superior Controls
Andre J. Petric, Kraemer US LLC
David Stokes, Venostic Solutions Group
Andrzej J. Szarmanski, GMDP Services
Richard S. Tessier, PE, Novartis Pharmaceuticals Corp.
Stephanie A. Wilkins, PE, PharmaConsult US Inc.
Bruce R. Williams, Williams Process Ltd.

Community of Practice (COP) Editorial Reviewers

Active Pharmaceutical Ingredients (API)

  • Andrew Gee, Boehringer Ingelheim Pharma
  • Zuwei Jin, Emerson Process Management
  • John Lepore, Merck & Co., Inc.

Biotechnology (Biotech)

  • Jeff Odum, CPIP, IPS
  • Steve Orichowskyj, Hargrove Life Sciences

Commissioning and Qualification (C&Q)

  • Petter Gallon, Gallon Partners AB
  • Peter Werner Christensen, Novo Nordisk A/S
  • Steve Wisniewski, CAI Consulting


  • Marc Abromovitz, Novartis Consumer Health Inc.
  • Peter Marshall, AstraZeneca Pharmaceuticals
  • Bob Sussman, SafeBridge Consultants, Inc.

Critical Utilities (CU)

  • Michelle Gonzalez, BioPharm Engineering Consultant
  • Phil Sumner, Pfizer


  • Yuk Chun Chiu, Bayer
  • Adam Goldstein, Genentech
  • Wayne Flaherty, Compliance Concepts International, Inc.
  • Pietro Perrone,EMD Millipore Corp.
  • John Stover, AdvantaPure/NewAge Industries

Good Automated Manufacturing Practice (GAMP)

  • Rory Budihandojo, Boehringer Ingelheim
  • Chris Clark, TenTenTen Consulting Limited
  • Tony Margetts, Factorytalk Co., Ltd.
  • Greg Ruklic, Systems & Compliance Professional
  • Sion Wyn, Conformity Ltd.

Heating, Ventilation, and Air Conditioning (HVAC)

  • Mel Crichton, Retired
  • Nick Haycocks, Amgen
  • Gary Knight, Commissioning Agents, Inc.
  • Don Moore, Eli Lilly & Co.
  • Norm Goldschmidt, Genesis Engineers Inc

Investigational Products (IP)

  • Esther Sadler-Williams, Catalent Pharma Solutions
  • Bob Misher, AndersonBrecon Clinical Supply Services
  • Robert Smith, Genzyme Corp.

Operations Management

  • Jim Curry, OpStat Group Inc.
  • Jim McKiernen, McKiernan Associates

Oral Solid Dosage (OSD)

  • Terry Jacobs, Jacobs Wyper Architects
  • Paul Egee, IMA North America
  • Dave DiProspero, CRB
  • Michael DeBellis, Jacobs Engineering Group, Inc.
  • Steve Sirabian, Glatt Air Techniques Inc.


  • Jim Robinson, Lachman Consultants

Process Analytical Technology (PAT)

  • Kevin Klopfer, Celgene Corp
  • Andreas Schneider, Roche Diagnostics International Ltd.

Project Management (PM)

  • Brian Beck, Zoetis Global Mfg and Supply
  • Jim McGlade, BHDP Architecture
  • Alf Penfold, Pfizer

Sterile Products Processing (SPP)

  • Alan Solomon, Baxter Healthcare Corp
  • Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co. KG

Sustainable Facilities

  • Nigel Lenegan, Energy & Carbon Reduction Solutions Ltd.
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