ORC Expert Advisory Services ORC International

  home    |    find an expert    |    request an expert    |    join our network    |    about us     expert login  
Expert Consulting and Expert Witness Services
  search tips 
Share this page:  Send to LinkedIn Send to Facebook Tweet This Email Print

 Expert  720664

Expert in Medical Devices, Biotech, Aseptic Processing, Engineering, Facilities, and Sterilization

Available for your Consulting and Expert Witness Needs

New Jersey (NJ)
Education Work History Career Accomplishments Consulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert has extensive expertise in all areas of aseptic processing and terminal sterilization of medical devices, human tissue for transplanation processing, microcontamination and controlled environments. He has been involved in clean room projects for Ethicon, Inc., Osteotech, Inc., Manufacturing Automation Corp.and Lonza, Inc. with over thirty years experience. He has supervised the construction and installation of several thousand square feet of clean room manufacturing area. His experience is in medical device manufacturing, involving the areas of packaging, filling, ultra pure water (WFI) and machine design.

Expert is a licensed professional engineer in New Jersey and Maryland.


aseptic filling


aseptic packaging process


clean room


medical device manufacturing


clean room design

Expert has extensive expertise in the manufacture of medical devices and biologics. Extensive experience in sterilization engineering and industrial sterilization processing and techniques using ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, and gas plasma sterilization. He has experience in ETO scrubbers and environmental monitoring. He is was involved with the very first peracetic acid gas plasma sterilizer.

industrial sterilization


sterile processing




sterilization engineering



Expert has extensive experience in the aseptic processing of human tissue for transplantation in addition to medical device sterilizaton techniques and processes.

Evaluation and implementation of predictable preventive maintenance programs, minimizing unscheduled downtime and maximizing maintenace and calibartion resources, all meeting FDA compliance requirements.

Experience in Master Site Planning. Leading planning activities, construction, commissioning and start-up of new FDA regulated facilities.


human tissue


maintenance management


medical device sterilization


site planning

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: New York, New York;  Yonkers, New York;  Newark, New Jersey;  Jersey City, New Jersey;  Paterson, New Jersey;  Elizabeth, New Jersey;  Bridgeport, Connecticut;  Stamford, Connecticut;  Philadelphia, Pennsylvania;  and Allentown, Pennsylvania.

Often requested
with this expert:

Validation of Sterilization Processes and USP/ AAMI...
Sterilization, Biomaterials, Tissue Banking, Medical...
Medical Products Packaging: FDA Package Validation,...
Safety Management in Industry and Construction

Year   Degree   Subject   Institution   Honors
1971   BS   Mechanical Engineering   City University of New York   President's List

Work History:
Years   Employer   Department   Title   Responsibilities

2008 to







Present Assignments: Assisting a major (Fortune 10) pharmaceutical company in their research integration effort, that will bring approximately 300 researchers and support staff from various Bioprocess Development departments to one site. The project includes both renovations to an existing 1.1MM ft2 facility and a new 139,000 ft2. research facility. Project budget is $157MM. Working with a Midwest biotech company processing purified DNA and Proteins. The challenge is to fully automate their filling, packaging and lyophilization processes in a new state of the art FDA regulated 150,000 ft2 facility. Past Assignments: Commercialization of a Multi-wave Ultrasound Elastography Breast Lesion Detection system. A new multi-wave ultrasound technology that provides imaging for precise, quantifiable results for early detection of breast cancer. Clinical support for a Bone Ultrasonic Scanner ™ (BUSS) is an ultrasound device that can be used to screen, diagnose and monitor osteoporosis through multi-parametric assessment of bone mechanical and structural characteristics. Assisting a start-up pharmaceutical company develop process, identify process equipment and meet regulatory compliance in order to begin manufacturing and bring API's in-house. Process Development: Providing technical support and knowledge based solutions to the Life Science Industry. Research, Identify and Perform Due Diligence for external manufacturing and third party suppliers. Site and Facilities Services: Plan, Design, and Build flexible, cost-effective and energy efficient processing areas and facilities all meeting Federal (FDA) Regulation and local codes. Provide Flexible, Customizable Aseptic Processing solutions for all pharmaceutical, medical device and biologic producers conducting Phase 1, 2, or 3 clinical trials to scale up and commercialization capability. Resolve compliance issues with FDA, EPA, State and Local authorities.

2007 to 2008


Lonza BioScience, Inc.




Vice Pres./Global Head of Engineering


•Member Leadership Sector Team report directly to President, Lonza Bioscience. Supporting sales of $2.87 billion. Support Lonza's position as leading innovator and supplier of cell-based solutions for the global pharmaceutical and biopharmaceutical research markets. •Responsible for four Domestic facilities and four International (Denmark, France, Singapore and Belgium) sites. •Direct overall engineering and technical activities for the global organization, relating to the creation, development and design of the organizations products, and facility infrastructure. •Head of Safety, Health and Environmental. •Capacity is over 5 billion adherent cells per manufacturing lot. •Lead all engineering activities and groups, site management maintain infrastructure, processing equipment, Master Site Planning, facility upgrades and new construction of aseptic cell therapy processing facilities.

2004 to 2007


Manufacturing Automation Corp.




Director, Technical Operations


Responsible for directing activities involved in process development, new product commercialization, facility expansion, auditing and validation. Develop Upfront process requirements and work closely with in-house and outside resources throughout project to assure requirements are met. Responsible for Process Development for FDA regulated products and processing facilities from concept through validation. Technical Development Lead on cross-functional multi-national new product development team. Developing the next generation disposable drug delivery systems, a needle-free injector designed for self-administration of a $3.5 Billion Ortho Biotech, Inc. (Johnson & Johnson) drug and a pre-filled Auto Injector device designed for self-administration of two new Centocor, Inc. (J&J) pharmaceuticals. Project budget was $28.1 Million. Product designed to meet Six Sigma quality requirements Project Lead on a $7 Million EtO sterilizer project for Guidant, Inc. Develop a fully automated system with minimal human interface. Researcher investigating novel sterilization sciences for a new micro woven product introduction from W.L. Gore & Associates, Inc. Proven Knowledge and Experience necessary to implement technology ideas and concepts early in the project life cycle. Interface with local, state and federal agencies on client's behalf. Define and Implement cost estimates, cost savings opportunities, utilizing Lean Manufacturing Techniques throughout the process development. Manage and deliver complex projects across a variety of geographic, company divisions and functions.

2003 to 2004


Progenitor Cell Therapy, LLC




Director, Engineering


Provide stem cell research and clinical services through a network of CGMP Aseptic processing facilities to medial products and pharmaceutical companies, assisting in their efforts to develop and market existing and emerging cell therapy products and treatments.

1989 to 2003


Osteotech, Inc.


Corporate Engineering


Director of Engineering


A global leader in the processing of human bone and connective tissue for the transplantation and an innovator in the development, manufacturing and marketing of biologic, biomaterial and device systems for musculoskeletal surgery. With a particular focus on spinal, trauma and total joint revision procedures, the company's current and development-stage technologies address needs within numerous musculoskeletal disciplines.

1976 to 1989


Ethicon, Inc. (Johnson & Johnson).




Project Engineering


A global medical device company and a leader in medical devices design and manufacture for more than 100 years with expertise in wound management, women's health and cardiovascular surgery. Part of the world's most comprehensive and broadly based manufacturer of health care products, it enjoys a reputation as the world leader in developing quality products to enhance the lives of patients and for providing outstanding service to customers. Presently conducts business in 52 countries and employs approximately 11,000 employees in its various worldwide locations.

Career Accomplishments:

He is a Licensed Professional Engineer in the State of New Jersey and Maryland.


Expert received Ethicon's Vice President Award for development and innovation of new products, and twice received the Johnson & Johnson Quality Award for cost savings and product implementation. This is Johnson & Johnson's most prestigious award.

Government Experience:
Years   Agency   Role   Description
2013 to   U.S. Army Medical Research Institute of Infectous Deseases   Project Executive   Project Executive for the new 931,000 ft2 U.S. Army Medical Research Institute of Infectious Diseases facility at Fort Detrick, MD. Provide strategic leadership for the construction, equipment installation, validation, commissioning and startup. This CDC regulated facility is the premier biodefense laboratory for the Department of Defense and the cornerstone of the Nation's interagency biodefense strategy. The facility incorporates the most stringent, state of the art biological high containment BSL2, BSL3 and BSL4 laboratories, clean rooms and vivarium. The project budget is $680MM.

Consulting Services:
Selected Consulting Examples:
  • Expert has been a retained consultant, concentrating on assisting executive management; focusing on auditing, validation, process development, facility expansion and development plans, correcting adverse FDA and other regulating agency findings. He has interfaced with local, state, and federal regulating bodies on client's behalf.
  • He developed detailed Master Plans for implementation, budget for location and design of three aseptic processing facilities nationwide for processing of vaccines.
  • Review of technical literature for litigation proceedings.
Recent Client Requests:
  • Expert for consulting on sterilizing endovenous laser fibers for re-use.
  • Expert for consulting on IVD Test Fluid Container Design.
  • Expert for consulting on EO sterilization and microbiology needed for Class III medical device.
  • EO sterilization expert specialist for 3rd party review of facilty.
  • Sterilization expert for consulting on SIP/CIP for mechanical seals and media mill grinding of industrial equipment for the bio industry.
  • Expert medical manufacturing for consulting on starting a medical manufacturing facility.
  • Expert in hydrogen peroxide vapor sterilization for consulting on H2O2 sterilization of aseptic process equipment.
  • FDA expert for consultation to provide pre approval and post approval support to ensure approval of a NADA with a minimum of time spent in the review cycle of T-Pro.
  • Expert sterilization etho for consulting on ETO Sterilization.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Sterilization expert for consulting on a sterilization process trade secret.
  • Tissue expert for consulting on cervical spacers.
  • Expert in FDA litigation for consulting on microbiological contamination of pharmaceuticals.
  • Hydrogen peroxide expert for consulting on peracetic acid.
  • Expert in medical devises for consulting on failure analysis of Endologix Powerlink catheter (SMDA).
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
1984 to 1988   South America   Expert assisted in the construction of aseptic processing facilities.
1994 to 1996   France   He worked on a tissue-for-transplantation processing facility.
2007 to 2008   Denmark/UK/Belgium/   He had responsibility for technical operations and facilities, supporting manufacturing and R&D.

Market Research:
Medical Device Manufacturing, Terminal Sterilization Parctices, Processing of Human Tissuefor Transplantation, Master Site and Facility Planning, Aseptic Processes.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Supplier and Vendor Location and Selection

Expert has experience locating vendors of: sterilization and sterilizers; clean rooms; machine shops able to fabricate very difficult and precise components and custom machine-design prototypes.

Other Skills and Services

He has experience in the scaling up of R&D products and projects into viable manufacturing processes. He also has an extensive aseptic processing, medical devices and background in machine design, component selection, machine shop practices, and prototype development.


Need the right expert?  We can help!

home       find an expert       request an expert       join our network       about us

Intota is now ORC Expert Advisory Services