— About

Arnan Ben-David

Independent Principal Consultant in Sterile Engineering with over 38 years of demonstrated history of working in the pharmaceutical and biopharmaceutical industry.

Arnan is not merely an advisor. He is the integrative engineering expert who bridges deep equipment knowledge, regulatory mastery across FDA and EMA frameworks, and decades of hands-on facility operations experience. His approach is rooted in standing on the owner’s side — providing an unbiased, technically rigorous perspective that protects investments and ensures projects are built correctly from the very first design decision.

At Teva, he served as Global Director of Sterile Engineering, overseeing 12 production sites worldwide. At Omrix / Johnson & Johnson, he led strategic projects including cross-site technology transfers and multi-million dollar facility constructions. Today, through 10AR, he brings that same global-scale expertise directly to each client — whether a multinational corporation or an emerging biotech startup.

Arnan Ben-David, principal sterile engineering consultant at 10AR

The "One Stop Shop" Philosophy

Arnan is not merely an advisor. He is the integrative engineering expert who bridges deep equipment knowledge, regulatory mastery across FDA and EMA frameworks, and decades of hands-on facility operations experience. His approach is rooted in standing on the owner’s side — providing an unbiased, technically rigorous perspective that protects investments and ensures projects are built correctly from the very first design decision.

At Teva, he served as Global Director of Sterile Engineering, overseeing 12 production sites worldwide. At Omrix / Johnson & Johnson, he led strategic projects including cross-site technology transfers and multi-million dollar facility constructions. Today, through 10AR, he brings that same global-scale expertise directly to each client — whether a multinational corporation or an emerging biotech startup.

Owner's Representative

In the pharmaceutical industry, engineering decisions carry enormous financial and regulatory consequences. Arnan provides a unique service as the owner’s representative — an impartial engineering authority who stands on the client’s side of the table.

He evaluates vendor proposals, challenges design assumptions, identifies hidden risks, and ensures that every specification genuinely serves the facility’s operational needs — not the vendor’s commercial interests.

Lyophilizer process and instrumentation diagram inspected during sterile production

Career Timeline

  1. 2018 — Present

    Independent Principal Consultant in the Field of Sterile Engineering (10AR – Sterile Engineering Solutions)

    Founded 10AR Sterile Engineering Solutions. Providing support to sterile manufacturing companies in all aspects of engineering — design, initiation, conceptual planning, equipment, systems, facilities, processes, qualifications, maintenance, and troubleshooting.

    • More than 30 clients including Teva, BTG, Rafa, Phibro
    • Partnering with 30+ clients worldwide — from top-tier pharma companies to innovative young ventures
    • Design, initiation and conceptual planning of sterile manufacturing facilities
    • Providing training in sterilization processes — including moist heat, dry heat — as well as in sterile homogenization
    • Equipment specification, procurement support and qualification
    • Process design, maintenance optimization and troubleshooting
    • Contributing to continuous production by generating compliant rationales/justifications and leading the investigation, documentation, and closure of deviations and CAPAs

  2. 2013 — 2018

    Teva Pharmaceutical Industries | Director – Global Engineering Sterile Production Network

    At Teva, he served as Global Director of Sterile Engineering, overseeing 12 sterile production sites worldwide.

    • Focal point for knowledge sharing — creation of collaboration and establishment of communities of practice for knowledge sharing and standardization
    • Ongoing support to the sterile network in projects, production issues and operations
    • Introduction of new technologies and assimilating them in production processes — detail design of automatic production processes
    • Global standards and guidelines writing — creation of URS's and technical specifications
    • Approval of sites' CAPEX plans

  3. 2008 — 2013

    Omrix Biopharmaceuticals (After the acquisition by J&J) | Director – Strategic Projects

    Company integrator for engineering activities and technology transfer between Omrix and other J&J sites worldwide.

    • Technical support and holistic overview of engineering activities
    • Feasibility studies for transferring products between sites of J&J
    • Participating in due-diligence between J&J and other companies
    Key Projects:

    • Project Manager — Transfer of lyophilized product from Israel to an abroad site: transfer of production process, complex logistics, acquiring quality and regulatory approvals (FDA, EU) until product reached J&J distribution warehouses in the US
    • Project Manager — Transfer the production of the biological glue syringe to another company to reduce costs
    • SME in the construction of 3 sterile manufacturing facilities

  4. 1998 — 2008

    Omrix Biopharmaceuticals | Chief Engineer and Engineering Department Manager

    Responsible for engineering activities across the plasma fractionation plant, aseptic filling lines, and R&D laboratories.

    • Built and managed the engineering, validation, calibration, and IT functions, including department recruitment and infrastructure setup
    • Managed CAPEX planning and supported BLA preparation, FDA / MCA inspections, and product approval activities
    • Represented Omrix in technology transfer and cooperation discussions with a Japanese Red Cross plasma component facility
    Key Projects:

    • Led the Jerusalem Fibrin Sealant plant project, including concept development, construction oversight, and scale-up of the production process
    • Added a sterile filling suite and lyophilizer in Stage II of the project
    • Contributed to the development of the Fibrin Pad product and its application machine
    • Improved fractionation and production capacity, including IVIG process upgrades and nanofiltration integration

  5. 1994 — 1998

    Teva Pharmaceutical Industries | Project Manager, SME for Equipment, Instrumentation, Control Systems and Calibrations

    Subject matter expert for equipment, instrumentation, control systems and calibrations.

    • SME of production technologies:
    — Sterile: autoclaves, depyrogenation oven, lyophilizers, automatic visual inspection machine, sterility testing isolator
    — Dry production: fluid bed drier, high shear mixer, V-mixer, coaters
    • Calibration Department Manager — activities and procedures
    • Divisional SME for instrumentation and control systems
    Key Projects:

    • Project Manager of purchasing, installation and qualifications of granulation equipment in a new dry production plant in Kfar Saba
    • Upgrading of control systems of legacy production equipment by adding PLC's for execution of automatic production processes and printing production reports
    • Purchase and installation of an automatic visual testing machine for lyophilized Copaxone
    • Establishment of a new calibrations laboratory in Kfar Saba site

  6. 1988 — 1993

    Abic | Maintenance Department Manager

    Responsible for all maintenance activities in the pharmaceutical plant (sterile, dry production, semi-solids, syrups and packaging), the chemical plant, the veterinary products unit and the veterinary vaccine plant.

    • Maintenance of chemical and microbiological laboratories
    • Management of 26 people
    • Construction of maintenance systems — computerized management system, procedures and training
    Key Projects:

    • Total renovation of two freeze dryers in the vaccine plant
    • Purchase and installation of packaging lines in the veterinary department