SUMMARY

Project Engineer / Manager in handling complete project cycle, including business, sales, marketing, capital approval, design, scheduling, budgeting, bid evaluation, construction management, commissioning, startup & validation.Process / Facilities Engineer wif experience in all aspects of engineering including design, R&D, pilot plant study, P&ID’s, PSM, troubleshooting & operations.

PROFESSIONAL EXPERIENCE

Confidential,Charlotte, NC

Process / Project / Validation Engineer

Responsibilities:

• Wrote User Requirement Specifications - URS for 6,000+ sq. ft. Quality Control / QC Production Lab wif 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, Boulder, CO
• Process Design for teh 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. dis constituted 15%+ of a $10,000,000 (10) plant remediation project. Created / modified 117 P&ID’s drawings. Wrote 50 page URS for High Voltage Leak Detection System / reviewed FRS / FS documentation. Merck, West Point, PA
• 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 dat have been out of service for 10 years. Biogen, RTP, NC
• Developed / wrote User Requirement Specifications for support of 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. Biogen, RTP, NC
• Investigation of comparison of Process Ranges versus Calibration Ranges of plant wide study wif focus / coverage of liquid nitrogen and refrigeration based Confidential dryers / lyophilizers, CIP, clean steam, diathermic fluid, liquid nitrogen, sterile air / nitrogen, refrigeration systems. Fresenius Kabi, Grand Island, NY
• Developed 1100 line MS Project Schedule for Installation / Validation of nine (9) consumer good projects. QualPak / GoJo, Laurinburg, NC
• 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. US Nonwovens, Brentwood, NY
• Project / Construction Manager for cell culture media CIP system which included 800 automatic sanitary welds for Mixer, Mill, Dispenser system. Lonza Bioscience / Cambrex Bioscience, Walkersville, MD
• Developed 18 P&ID’s for teh upgrade / enhancement of bleaching & refining plus designs for reducing water & steam consumption for (2) edible oil plants. Cargill, Charlotte, NC, Cargill, Sioux City, IA
• Identified 15 API Plant Safety Issues. Developed Scope of Work and Designs for correction. Irix Pharmaceuticals / Patheon, Greenville, SC
• Designed & developed bid packages for filtration, ultrafiltration, diafiltration, CIP & chromatography skids. bioMerieux, Durham, NC, Talecris Bio therapeutics, Clayton, NC, Wyeth, Sanford, NC, Haemacure, Sarasota, FL
• Developed design & construction documentation for single use bioreactor installation, single-use centrifuge test room, and caustic kill / acid neutralization system modifications along wif other utility upgrades. KBI Biopharma, Durham, NC, KBI Biopharma, RTP, NC,
• Developed multiple infrastructure & process improvement / addition projects for adhesive, coating & agricultural intermediates projects to add plant capacity, improve operations & reduce costs. Coatex, Chester, SC, Chemdal, Aberdeen, MS, EON Labs / Novartis, Wilson, NC
• Developed P&ID’s for an active pharmaceutical ingredient - API - Thin Film Evaporation CIP system. Completed estimates for Design Qualifications (DQ), IQ & OQ along wif preliminary scope / system integrator interviews for a 21 CFR Part 11 compliant Intellution batch control system. Technology Development Corporation, Charlotte, NC
• 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, Lincoln, NE, Confidential, Terre Haute, IN, Protein Design Labs / PDL BioPharma, Plymouth, MN
• Wrote Regulatory & Complexity Assessment (RCA), SRS & IQ, OQ and / or PQ documentation for Colloid Mill, CIP, SIP - Steam in Place & USP Water process systems. Wrote dispensing / vial filling IQ, OQ & Cold Room Automation Systems Requirement Specifications (SRS) for biotech / protein manufacturers. EMD Millipore / Merck KGaA, Kankakee, Tyco Healthcare / Mallinckrodt, Maryland Heights, MO, Indiana Protein Technologies, Greenwood, IN
• Completed Gap Analyses for 50 plus Pharmaceutical Processes / Equipment and Utility Systems. GSK, Aiken, SC
• 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 teh same. Argos Therapeutics, Durham, NC
• Site Evaluation / Process Development / Design. Greer Labs, Lenoir, NC, bioMerieux, Durham
• Site Evaluation / Review / Turn Over Package (TOP) Development for CIP, Compressed Air, Nitrogen, HVAC, Boiler and Electrical Systems. Pearl Therapeutics, Durham, NC
• Design / URS review of USP Water, Tekemas Resin Formulation, Media Formulation, and CIP Systems for Line 4 BacT/ALERT Culture Media. bioMerieux, Durham
• Performed pre start up review of new surfactant / Polyvinylpyrrolidone (PVP/PVPi) pharmaceutical / excipients / prill plant. BASF, Geismar, LA
• Process Safety Management – PSM for epoxy, defoamer and acrylic monomer / photomer manufacturer wif focus on electrical, steam, water, wastewater and piping systems. Participated in ISO 14001 re certification. IGM Resins, Charlotte, NC
• Process Engineer for design, commissioning, startup of $3,000,000 Boiler / Boiler Feed Water, Condensate Polishing, Deaerator / 3D Trasar and teh FEL-3 design for a $2,000,000 per year energy recovery project. International Paper, Ticonderoga, NY, DuPont, RTP, PCS Phosphate, Aurora, NC

Confidential,Wyeth, Marietta, PA

Project Engineer / Manager

Responsibilities:

• Developed designs for $10,000,000 Vaccine Development Center renovation. Created database for utility requirements, relocation, calibration & installation of 450 pieces of laboratory equipment.
• Managed $750,000 Clinical Live Virus Aseptic Filling / Lyophilization Project from Scope of Work & Basis of Design through Engineering Turnover Package & Commissioning. First project to incorporate Corporate Project Management & Commissioning SOP & HVAC Engineering Standards.
• Led Scope of Work & Design for $500,000 Biosafety Level – 2 (BL-2) Clinical Filling / Confidential Drying enhancement project.
• Developed designs for $400,000 cGMP – small pox vaccine warehouse lighting / security project & $250,000 clinical packaging relocation.
• Plant representative during construction for Cold Adaptive Influenza Vaccine (CAIV) facility expansion.

Confidential,Charlotte, NC

Project Engineer / Manager

• Interim Plant Engineer / Manager for agricultural intermediate contract specialty chemical manufacturer. Organized plant information, interfaced wif customers, participated in HAZOP reviews & executed multiple process & facility projects. Clariant / Nipa Hardwicke, Rock Hill, SC
• Lead Process Engineer for teh design / upgrade of USP water, DI Urea, chemical & waste inactivation systems for insulin, parathyroid & human growth hormone manufacturer. Eli Lilly, Indianapolis, IN

Confidential,Lansing, MI

Mechanical Engineer - Project Engineer / Manager

• Project Manager for $2,500,000 chiller, centrifuge, CIP & neutralization system project for producing Human Plasma Derivatives Fraction II - Immune Globulin & Fraction V - Albumin.
• Project Engineer for $100,000 albumin pasteurizer relocation / controls enhancement project. Enhancements added 3 levels of protection against a $450,000 product loss.
• Improved process safety for anthrax vaccine fermentation & separation process.gineer.