Biotechnology Process Design Consultant for Food, Pharmaceutical, and Specialty Chemicals

Expertise

• Biotechnology, food, pharmaceutical and specialty chemicals.
• A broad background with strong technical skills that includes business, sales, and marketing; design, construction and start-up; pilot plant, research and development, and operations.
• Project Engineer and Manager in handling complete project cycle, including feasibility, sales, marketing, detailed design, planning, scheduling, budgeting, capital approval, specification, vendor selection, bid evaluation, construction management, plant start-up, engineering turn over and validation.
• Process and Facilities Engineer with experience in all aspects of process and utility engineering including conceptual design, research and development, pilot plant study, generation of PFD (Process Flow Diagrams) and P&ID's, (Piping and Instrumentation Diagram) technical support, trouble shooting, start-up, commissioning, validation and operations.
• National and international technical support: Canada, China, Egypt, Belgium, Germany, Italy, Japan and United States (29 States).

Experience

Independent Consultant, Project Engineer and Manager, 2002 - Present

Projects

• Process Design for the filtration and sampling of (7) Cell Factory, (1) Microfiltration, (1) Ultra filtration, (3) Fermentation, (3) Acid/Base, (5) Media Preparation / Hold, (1) Recovery Tank Systems and (9) CIP Systems.
• Constituted 15%+ of a $10,000,000 (10) plant remediation project. Created / modified 117 P&ID’s drawings.
• Developed 1100 line MS Project Schedule for installation and validation of 9 consumer good projects. QualPak / GoJo.
• Project Manager for design and installation of blend skid for production of nonwoven wet wipes.
• Developed process for zero discharge and CIP – Clean in Place blend skid.
• Project and Construction Manager for cell culture media CIP system which included 800 automatic sanitary welds for mixer, mill, dispenser system.
• Developed 18 P&ID’s for the upgrade and enhancement of bleaching and refining bleaching and refining plus designs for reducing water and steam consumption for (2) edible oil plants for Cargil.
• Identified 15 API Plant Safety Issues. Developed Scope of Work and Designs for correction. Irix Pharmaceuticals / Patheon.
• Designed and developed bid packages for filtration, ultra filtration, diafiltration, CIP and chromatography skids. (bioMerieux, Durham, NC, Talecris Bio therapeutics, Clayton, NC, Wyeth, Sanford, NC, Haemacure.)
• Developed design & construction documentation for single use bioreactor installation, single-use centrifuge test room, and caustic kill / acid neutralization system modifications along with other utility upgrades. KBI Biopharma, Durham, NC, KBI Biopharma, RTP.
• Developed multiple infrastructures - process improvements and addition projects for adhesives, coatings and agricultural intermediates projects to add plant capacity, improve operations and reduce costs. (Coatex, Chester, SC, Chemdal, Aberdeen, MS, EON Labs / Novartis)
• Developed P&ID's for an active pharmaceutical ingredient - API - Thin Film Evaporation CIP system. Completed estimates for Design Qualifications (DQ), IQ & OQ along with preliminary scope / system integrator interviews for a 21 CFR Part 11 compliant Intellution batch control system. (Technology Development Corporation.)
• Wrote and (or) approved change control commissioning, Functional Requirements Specifications (FRS), Remediation and Validation Plans (R&VP), validation trace matrixes, Automation Installation Qualifications, (AIQ), Automation Operational Qualifications (AOQ) and Performance Qualifications (PQ) for biological products infrastructure and water for Injection building management systems (BMS).
• Participated in AIQ / AOQ and /or FMEA of HVAC, airlock / door, compressed gas, utilities, OTC / solid dose manufacturing, USP Water and / or media / buffer preparation - bioreactor process systems.
• Conducted quality review, oversight, approval of utility systems.
• Wrote Regulatory and Complexity Assessment (RCA), SRS and IQ, OQ, or PQ documentation for colloid mill, CIP, and SIP, (Steam in Place) and USP, (United States Pharmacopoeia) water process systems.
• Wrote dispensing and vial filling, IQ, OQ, cold room Automation Systems Requirement Specifications (SRS) for biotech and protein manufacturers. (EMD Millipore / Merck KGaA, Kankakee, Tyco Healthcare / Mallinckrodt, Maryland Heights, MO, Indiana Protein Technologies.)
• Process Engineer for design, commissioning, start-up of $3,000,000 boiler and boiler feed water, condensate polishing, deaerator / 3D Trasar and the FEL -3 design for a $2,000,000 per year energy recovery project. (International Paper, Ticonderoga, NY, DuPont, RTP, PCS Phosphate.)

Accomplishments

• Provided guidance and justification for a pilot plant for the production of almond milk and almond snacks. Blue Diamond Growers.
• Reviewed Water Systems for the production of 18O Isotope Water and Positron Emission Tomography (PET) - Nuclear Imaging and 13C Isotope / Urea Inhalation per FDA Request. CIL Isotope Separations.
• Developed twenty-four (24) Cause and Effect Diagram / Fishbone / Ishikawa Diagrams from review of 18O Isotope plant for the following systems – USP Water, 13 Stage Multi-Effect Cascade, Single Step Distillation, Ion Exchange, Electro Dialysis, Furnace, Cold Trap, Cryogenic Trap, Normalization Reactor, Collection, UV / Ozone and Packaging Systems. CIL Isotope Separations.
• Developed and wrote User Requirement Specifications for support of ASO – Antisense Oligonucleotide Synthesis Manufacturing Process for 1) Ammonium Hydroxide Addition, 2) 3-Picoline Addition, 3) Dichloroacetic Acid – DCA Addition, 4) Toluene Bulk System, 5) Acetonitrile Bulk System, 6) Deblock – DCA / Toluene, 7) Sulfurization – acetonitrile / 3-Picoline Solution Preparation System, 8) Activator Solution Prep and 9) SP- Scientific LyoStar 3 Laboratory Scale Lyophilizer as part of GE OG Synthesizer Project. SMA – Spinal Muscular Atrophy – SMN1 gene Biogen, RTP, NC http://www.ionispharma.com/ionis-spinraza-recognized-prestigious-prix-galien-award-best-biotechnology-product.
• Wrote User Requirement Specifications – URS for 6,000+ sq. ft. Quality Control / QC Production Lab with 93+ major pieces of equipment. Systems included; Building Management – BMS, Carbon Dioxide – CO2, Communications, Compressed Air – CA, Data, DI Water / ASTM D1193-06 Reagent Grade Type II - Type B / ASTM D5196-06 Bio-Applications, Electrical, Helium – He, Hydrogen – H2, Natural Gas – NG, Nitrogen – N2, Potable Water – PW and Vacuum – VAC. Astra Zeneca / Medimmune.
• Wrote 50 page URS for High Voltage Leak Detection System / reviewed FRS / FS documentation. Merck.
• Process Design for converting existing COP – Clean-Out-of-Place Skid to Semi CIP system for cleaning 30 liter formulation vessels. Project included P&ID Modifications, General Piping Arrangement / Construction Specifications and rebuilding components that have been out of service for 10 years. Biogen, RTP.
• Investigation of comparison of Process Ranges versus Calibration Ranges of plant wide study with focus / coverage of liquid nitrogen and refrigeration based freeze dryers / lyophilizers, CIP, clean steam, diathermic fluid, liquid nitrogen, sterile air / nitrogen, refrigeration systems. NY
• Project Manager for design / installation of Blend Skid for production of nonwoven wet wipes. Developed process for zero discharge / CIP – Clean in Place Blend Skid - $300,000. U.S. Nonwovens.
• Project / Construction Manager for cell culture media CIP system which included 800 automatic sanitary welds for Mixer, Mill, Dispenser system - $250,000. Lonza Bioscience / Cambrex Bioscience.
• Developed design & construction documentation for single use bioreactor installation, single-use centrifuge test room, and caustic kill / acid neutralization system modifications along with other utility upgrades. KBI Biopharma, Durham, NC, KBI Biopharma, RTP.
• Wrote and / or approved Change Control, Commissioning, Functional Requirements Specifications, Remediation & Validation Plans, Trace Matrixes, Automation Installation & Operational Qualifications, (AIQ) & (AOQ) and Performance Qualifications (PQ) for biological products infrastructure, USP Water System & Water for Injection - Building Management Systems (BMS). Participated in AIQ / AOQ and /or FMEA of HVAC, airlock / door, compressed gas, utilities, OTC / solid dose manufacturing, USP Water and / or media / buffer preparation - bioreactor process systems. Quality Review / Oversight / Approval of utility systems. Bayer, Clayton, NC, Astra Zeneca / Medimmune, Frederick, MD, Novartis / GSK – OTC, Pfizer, Protein Design Labs / PDL BioPharma.
• Completed Gap Analyses for 50 plus Pharmaceutical Processes / Equipment and Utility Systems. GSK.
• Quality review / development of User Requirement Specifications (URS) for Clean Room, UPS Water, Nitrogen, Carbon Dioxide, Emergency Power, HVAC and Compressed Air Systems. Drawing review for the same. Argos Therapeutics.
• Site Evaluation / Process Development / Design. Greer Labs, Lenoir, NC, bioMerieux.
• Site Evaluation / Review / Turn Over Package (TOP) Development for CIP, Compressed Air, Nitrogen, HVAC, Boiler and Electrical Systems. Pearl Therapeutics.
• Design / URS review of USP Water, Tekemas Resin Formulation, Media Formulation, and CIP Systems for Line 4 BacT/ALERT Culture Media. bioMerieux.
• Performed pre start up review of new surfactant / Polyvinylpyrrolidone (PVP/PVPi) pharmaceutical / excipients / prill plant. BASF.
• Process Safety Management – PSM for epoxy, defoamer and acrylic monomer / photomer manufacturer with focus on electrical, steam, water, wastewater and piping systems. Participated in ISO 14001 re certification. IGM Resins.

Wyeth, American Home Products, Project Engineer - Manager, Marietta, PA, 2001 - 2002

• Managed $750 thousand clinical live virus aseptic filling lyophilization project from scope of work and basis of design through engineering turnover package and commissioning.
• First project to incorporate corporate project management and commissioning SOP and HVAC engineering standards.
• Developed designs for $10 million vaccine development center renovation.
• Created database for utility requirements, relocation, storage, calibration and re-installation of 450 pieces of laboratory equipment.
• Led scope of work and design for $500 thousand biosafety Level - 2 (BL-2) clinical filling and freeze drying enhancement project.
• Developed designs for $400 thousand cGMP small pox vaccine warehouse lighting and security project and $250 thousand clinical packaging relocation.
• Plant representative during construction of 25,000 sq. fl2 cold adaptive Influenza vaccine (Cal-V) facility and 5,000 sq. ft. expansion design for 100% increase in system capacity.

Independent Consultant, Project Engineer and Manager, Charlotte, NC, 2000 - 2001

• Lead Process Engineer for the design and upgrade of USP water, 01 Urea, chemical and waste inactivation systems for insulin, parathyroid and human growth hormone manufacturer.
• Interim Plant Engineer and Manager for agricultural intermediate contract specialty chemical manufacturer.
• Organized plant information systems and interfaced with customers.
• Participated in HAZOP reviews and executed multiple process and facility projects.

Emergent Biosolutions, Lansing, MI, Mechanical Engineer, 1993 - 1999

• Project Manager for $2 million chiller, centrifuge, CIP and neutralization system project for producing human plasma derivatives fraction II - immune globulin and fraction V - albumin.
• Project Engineer for $100 thousand albumin pasteurizer relocation and controls enhancement project.
• Enhancements added; 3 levels of protection against a $450 thousand product loss. Assisted in commissioning and validation of system.
• Improved process safety for anthrax vaccine fermentation and separation process.

Project Engineer and Manager, 1993 - 1998

• Designed process for converting animal blood from a traditional $600 per ton to a value added $3,800 per ton product. Conducted pilot studies on collection, centrifugation, filtration, evaporation, membrane concentration and spray drying for separating cellular fraction and drying plasma fraction.
• Managed the design, purchase and construction contracts of a tissue cell production architectural renovation and upgraded biologics project.
• Team leader for the development and implementation of ISO 14000 program for an animal biological vaccine manufacturer.
• Developed process design for an emulsification upgrade project to increase vaccine efficacy, enhance production flexibility and reduce cycle time 40% eliminating a second shift.
• Corporate project engineer for 4 specialty chemical plants in the U.S.A. and Canada.
• Expanded two plants and worked to close two plants while executing 22 facility and process infrastructure upgrade projects.

Marathon, (Jaakko Poyry), Process / Project Engineer - Manager, Augusta, GA, 1991 -1992

• Managed design, construction, and start-up of a $3 million polymerization process addition increasing capacity 350%.
• Provided project management for client and for engineering company.
• Completed all remaining project management and engineering commitments as the last working employee during the closure of Marathon's southern engineering office.

Rhodia, Rhone Poulenc, Plant Engineer - Engineering Manager, Spartanburg, SC, 1989 - 1991

• Managed all project and engineering, environmental, maintenance, and utility functions.
• Managed the design, construction, HAZOP and start-up of a $1 million ethylene oxide derivatives - surfactants batch reactor project improving cycle times 35%.
• Assisted in the design, permitting and construction of a $2.5 million wastewater treatment plant and a $9 million phosphate ester batch reactor process, warehouse, tank farm, GMP drumming and DCS project.

CH2M HiII, (Lockwood Greene), Spartanburg, SC, 1983 - 1989

Process: Mechanical Project Engineer - Manager

• Leading High Tech Pharmaceutical income producing project manager for over a year.
• Projects focused on the design, troubleshooting and start-up of microelectronics pharmaceutical process and utility systems.

MEMC, Monsanto, Facilities - Utilities, Engineer, Spartanburg, SC, 1980 - 1982

• Coordinated acceptance; start-up, tie-in and operation of utilities with each new manufacturing department of a 14-month construction and start-up of the world's largest silicon wafer plant.
• Set up pure water analytical laboratory.
• Influential in creating a new business of analyzing pure water quality and designing ozonated pure water systems.
• Managed utility systems and maintenance and operation technicians.

Dow Chemical - Union Carbide, S. Charleston, WV, 1975 -1980

Technical Center: Process and Project Engineer

• Business team member for the design, development, marketing, and sales of pure oxygen biological reactor and disinfection chemical enhancement ozonation systems.
• Start-up engineer for several of the world's largest industrial ozonation and wastewater treatment plants.
• Wrote corporate guidelines for contract waste disposal.

Honors & Publications

Credentials

• P.E. West Virginia, South Charleston, WV
• Over 30 hours, PDH's, per year requirement to maintain Professional Engineering Registration.
• Marshall University-American University, Cario, Chemical Engineering / International Studies - Master Degree Level Course Work.
• Michigan State University: MS Sanitary Engineering
• BS Mechanical Engineering
• Student Advisory Member to the Chairperson of Mechanical Engineering - 2 year elected position.
• Received / Awarded scholarships from High School, Mechanical & Civil Engineering Departments.
• Graduate Teaching Assistant for Environmental, Hydraulics & Surveying Labs.
• Engineering Employment in Civil Engineering, Quality Assurance, Testing & Development, Plant Engineering & Construction.

Academic and Professional Affiliations

Providing teaching presentations for venues over 900 attendees for the following:

• American Chemical Society, (ACS)
• Association for Facilities Engineering, (AFE)
• American Institute of Chemical Engineers, (AIChE) NC and SC, 25 (High Purity Water), 12 (Part 11 Compliance), 21 (Waste Water Treatment)
• American Society of Mechanical Engineers, (ASME), 22 22 (High Purity Water), 67 (Waste Water Treatment)
• Construction Specifications Institute, (CSI), NC - 23
• High Tech & Pharmaceutical Conference, Brussels, Belgium - 55
• Interuniversity Microelectronics Center, (IMEC), Leuven, Belgium - 10
• Johnson & Johnson, NJ and PA - 110, 10
• Kemet Electronics, Greenwood, SC - 10
• Lockwood Greene, Spartanburg, SC - 40
• Lockwood Greene, Plano, TX - 10
• Novozymes, Salem, VA - 12
• Pennsylvania Society of Professional Engineers Philadelphia Section, (PSPE), Philadelphia, PA - 27
• North Carolina South Piedmont Chapter of Professional Engineers, (PENC), Charlotte, NC - 26
• Texas Instruments, Richardson, TX - 25
• MS Project Training, Wachovia, Winston Salem, NC - 16
• MS Excel Training, Computer Education Services, Charlotte, NC - 10
• Microsoft - CTS Service Ready (Mission Critical / Technical Support) - 300

Education

• M.S. Sanitary Engineering, Michigan State University, East Lansing, MI
• B.S. Mechanical Engineering, Michigan State University, East Lansing, MI