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

Technical Consultant #2016


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

  • 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.
  • 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 plus designs for reducing water and steam consumption for (2) edible oil plants.
  • Identified 15 API plant safety issues.
  • Developed scope of work and designs for correction.
  • Designed and developed bid packages for filtration, ultra filtration, diafiltration, CIP and chromatography skids.
  • Developed design and construction documentation for single use bioreactor installation, single use centrifuge test room, and caustic kill / acid neutralization system modifications along with other utility upgrades.
  • Developed multiple infrastructures - process improvements and addition projects for adhesives, coatings and agricultural intermediates projects to add plant capacity, improve operations and reduce costs.
  • 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.
  • 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.
  • 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.

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.

Proengineer, 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
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