Chemical and Pharmaceutical Process Simulation and Design Consultant

Technical Consultant #1562


Expertise

  • Chemical process design, engineering, and troubleshooting of organic and inorganic processing plants.
  • Directing process engineering project teams for the preparation of process evaluations, cost studies, preliminary and detailed design, PFD's, P&ID's, heat and material balances, equipment design specification.
  • Heat and material balances (HMB).
  • Equipment scale-up.
  • Polymerization.
  • Hydraulics, distillation, and plant utilities.
  • Vaccine compounding and vaccine formulation.
  • Vial filling Lines.
  • Water for Injection (WFI) systems.
  • Clean utilities.
  • Clean in Place (CIP), Sterilize in Place and Steam in Place (SIP).

Experience

Undisclosed Company, Processing Engineering, 2015 - 2017
Project
Sanofi Pasteur

  • Lead Process Engineer working on the detailed design of new manufacturing facilities for the production of flu vaccines in three different countries, (USA, France and Mexico).
  • Primary responsibilities included: Water for injection and Clean Steam production, storage, and distribution: Installation of clean steam generator and verification and commissioning of a bulk solvent weighing and dispensing system.

Middough, Inc., Senior Process Engineer, 2015
Project
Croda

  • Created detailed design of a new chemical manufacturing facility at Croda's Atlas Point Plant in Delaware.

Integra LifeSciences, Plainsboro, NJ, Process Engineer, 2010 - 2015

  • Executed engineering for the custom, one-of-a-kind equipment, and clean-in-place systems and their integration into the process transfer to a new manufacturing facility.
  • Previous project; the "reverse engineering" of an existing one-of-a-kind adhesive coating machine and a die cutter for the purpose of fabricating new machines to enable an expansion of production capacity. These machines operate in an ISO 5 environment.

Fluor, Inc., Process and Project Engineer, 2001 - 2010
Projects
Bristol-Meyers Squibb
Potent Compounds Weigh 8. Sampling Area, CSO Containment Weigh Suite

  • Detailed design for the potent compounds weigh and sampling area. The area included two new raw material and API weigh suites to accommodate Band 1 through 3 materials and two to accommodate Band 4 and 5 compounds.
  • In addition the area included a staging area, component sampling room, and wash suite.
  • Major new equipment included a weigh isolator, CIP skid, flow sciences enclosure, downflow booths, walk-in refrigerator and freezer, and waste neutralization skid.

Facility Utility Design Guide

  • Authored the BMS design standard for facility utility systems. A prescriptive guide for new facilities or facility expansion. Included were decision trees for the selection of utility system configurations and equipment.

Small and Intermediate Volume Manufacturing, Barceloneta, Puerto Rico

  • Process engineer responsible for preparing P&IDs and equipment specifications in support of the conceptual design study to transfer manufacture of sterile and non-sterile steroid and non-Iactam products from BMS's Humacao plant to their Barceloneta, Puerto Rico facility.
  • The manufacturing facility was designed to handle the current production forecast requirements, but was additionally master-planned to accommodate future sterile potent compound production. The facility was designed employing barrier isolation technology to achieve containment and reduce the aceptic envelope.
  • Three design options were generated with varying layout and train configurations ranging in total cost from $90 to $150 million.

Roche Molecular Systems, Branchburg, NJ, Process Engineer

  • Working as process, piping and project engineer for the installation of a clean steam generator.
  • Verification and commissioning of a bulk solvent weighing and dispensing system.
  • Process, piping and project engineer for the installation and integration of an oil-free air compressor producing clean compressed air.
  • Developed and wrote change control documentation.
  • Developed and wrote system commissioning plans.
  • Developed and wrote preventive maintenance plans.

Engineering Studies Project

  • Conducted engineering studies to determine the cause of problems and deficiencies observed in various systems including high purity water (PCRW) production, storage and distribution as well as CIP supply, distribution, and sprayballs.
  • Developed hydraulic models to assist in analyzing the systems and proposed modifications to pumps, valves, orifices, sprayballs, etc.
  • Conducted tests to demonstrate that the desired results had been achieved. Worked with the construction, validation, operations, and facilities groups to make, verify, and validate changes.
  • Prepared and executed Installation and Operation Qualification (100) documentation.

DSM Nutritional Products, Belvedere, NJ, Supervisor

Neutraceutlcal Manufacturing Facility-Fermentation House Expansion

  • Supervising process engineer for $23 million project to produce the basic engineering design (BED) and detailed design for the expansion of an existing fermentation house and a new downstream process (DSP).
  • Involved the reactivation of idle fermenters for the production of a biomass with an intracellular product. ~Design of fermenter raw material systems including phosphoric acid truck unloading, storage, caustic distribution, and growth media (dextrose) railcar unloading, storage and sterilization.
  • Design and specification of product harvest system and DSP including belt filter, extruder, fluid bed dryer, baggers, and corresponding CIP system. Participated in HAZOP and value engineering sessions. Provided inter-discipline support and field design coordination.

Raytheon Engineers & Constructors, 1974 - 2001

Projects:

Merck, West Point, PA, Vaccine Process Facility

  • Assisted Merck in preparing the preliminary design, PFDs, and P&IDs for a confidential vaccine process facility. Seconded as a member of Merck's sterile processing technology and engineering group.

Wyeth, Pearl River, NY, Lead Process Engineer

  • Oversaw project's basis of design (BOD) and the project detailed design to upgrade the utilities for the B211 vaccine manufacturing and research building.
  • Major equipment for the project included a water pre-treatment system to produce United States Pharmacopoeia (USP) purified water at a capacity of 20 gpm.
  • The new equipment and systems were designed to supplement the existing operating utility systems; and as such, required significant study of system tie-ins design and planning to minimize impacts to the existing operations.
  • Plant utilities such as plant steam, city water, and compressed air were extended to the new facility from tie-ins in the existing facility.
  • The existing chilled water system had no reserve capacity, so a new 100-ton air-cooled chiller was provided to serve the new facility process cooling needs via a separate closed loop cooling system.

Tetrlonlcs, Madison, WI, Supervisor

Batch Organic Synthesis

  • Supervising process engineer for batch organic synthesis design of a multipurpose, multiproduct kilo-lab facility for the production of analoga and derivitives of vitamin D.
  • Reactions were carried out at temperatures ranging from 180℃ to -78℃. A cGMP harvest room was included for product recovery.
  • A single-fluid heating I cooling was incorporated that supplied heat transfer fluid from two loops - a hot loop at 200℃and a cold loop at -30℃. Lower temperatures for the reactors were achieved using liquid nitrogen at the reactor stations.

United States Department of Defense, Johnston Island, Pine Bluff, AR, and Umatilla, OR

Thermal Oxidizers

  • Supervising process engineer involved material and energy balances, unsteady state heat transfer, and residence time studies for thermal oxidizers in support of trial burn plans for destruction of chemical agents.
  • Design was in support of environmental permits for submission to the United States Environmental Protection Agency (EPA).

Sandoz, Ringaskiddy, Cork, Ireland, Supervisor

Phase II and III Bulk Pharmaceutical

  • Supervising process engineer involved in two separate projects.
  • Lead process engineer supervising seven engineers and five CADD designers in preparing a fully integrated (multi-discipline) 3D CADD design for a facility expansion.
  • The processes involved the purification of a bulk pharmaceutical by means of physical separations, crystallization, column chromatography, solids drying, milling, blending, handling and solvent recovery.
  • Prepared the specifications for testing of the various DCS programming modules.

Mobil Chemical Co., Exton, PA, Process Engineer

Organic Chemical Additive

  • Lead process engineer for the preliminary design of a batch organic process to produce calcium phenate.
  • Coordinated the technical work of nine process engineers as they developed detailed heat and material balances, P&IDs, and equipment specifications in support of a project appropriation estimate. Process design included hazardous chemicals.

ARCO Chemical Co., Engineer

Polymers Department, Rieme, Belgium

  • Lead process engineer for an organic process design involving hazardous chemicals, including ethylene oxide to produce polyols and polymer polyols.
  • Participated in the detailed design effort which was conducted in The Netherlands.

Organic Chemicals, Bayport, TX

  • Process engineer for the process design of an organic chemical plant to produce propylene glycols.
  • Developed detailed process flow diagrams, P&IDs, and equipment specifications in the product recovery areas, which included 10 distillation columns.

ICI Americas, Fayetteville, NC Polyether Sulfone Plant, Process Engineer

  • Lead process engineer for an organic and polymer plant design.
  • Process included batch monomer dissolution and polymerization steps, followed by continuous solvent and product recovery which included vacuum thin film evaporation. High temperature (600℉) heat transfer fluid was used for temperature control of the jacketed equipment and piping.

American Cyanamid Company, Linden, NJ and Fortier, LA, Process Engineer

Specialty Chemical Facility

  • Lead process engineer for the engineering and design of a catalytic acrylamide monomer plant which utilized a vacuum thin film evaporator to remove unreacted volatiles from a viscous organic.
  • Other projects included a boiler conversion, off-site facilities, process waste treatment facilities, and an ammonia pipeline pumping station.

Honors & Publications

Academic and Professional Affiliations

  • American Institute of Chemical Engineers-AIChE

Education

  • M.S. Chemical Engineering, Drexel University, Philadelphia, PA
  • B.S. Chemical Engineering, Grove City College, Grove City, PA
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