Project Engineer / Manager in handling complete project cycle, including business, sales, marketing, capital approval, design, scheduling, budgeting, bid evaluation, construction management, commissioning, start up & validation.
Process / Facilities Engineer with experience in all aspects of engineering including design, R&D, pilot plant study, P&ID’s, trouble shooting & operations.
Biopharm / Consumer Goods / Food / Microelectronics / Specialty Chemical Industries
1 PROENGINEER, CHARLOTTE, NC 2002 - PRESENT
Project Engineer / Manager
Process Engineer for boiler, blend skids, CIP – Clean in Place, energy recovery, and filtration projects.
Developed P&ID’s for increasing performance of edible oil processing, reducing water / steam consumption and addressed API Safety Issues.
Designed & developed bid packages for filtration, CIP & chromatography skids.
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 biotechnology and pharmaceutical plants. Participated / executed AIQ / AOQ’s / FMEA for USP Water and media / buffer preparation / bioreactor process systems.
Wrote Regulatory & Complexity Assessment (RCA), SRS & IQ, OQ and / or PQ documentation for biotech / pharmaceutical production / utility systems.
PFIZER / WYETH, MARIETTA, PA – SITE CLOSED 2001 - 2002
Project Engineer / Manager
Engineer / Manager for all Building 32 clinical manufacturing / R&D projects.
1 PROENGINEER, CHARLOTTE, NC 2000 – 2001
Project Engineer / Manager
Interim Plant Engineer / Manager for agricultural intermediate contract specialty chemical manufacturer.
Lead Process Engineer for the design / upgrade of insulin, parathyroid & human growth hormone manufacturer.
EMERGENT BIOSOLUTIONS / BIOPORT, LANSING, MI 1999
Mechanical Engineer - Project Engineer / Manager
Project Manager for plasma derivatives centrifuge /CIP / pasteurizer projects.
1 PROENGINEER, CHARLOTTE, NC 1993 – 1998
Project Engineer / Manager
Designed process for producing animal plasma feed products, developed process design for an emulsification upgrade project, and helped implement ISO 14000 program for a vaccine manufacturer.
Corporate project engineer for the upgrade of two plants & closure of two adhesive plants.
EDUCATION
MICHIGAN STATE UNIVERSITY
MS Sanitary Engineering
BS Mechanical Engineering
Professional Engineer WV 007800
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. This constituted 15%+ of a $10,000,000 (10) plant remediation project. Created / modified 117 P&ID’s drawings. Merck, West Point, PA
Developed 1100 line MS Project Schedule for Installation / Validation of nine (9) consumer good projects. QualPak, 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 / Cambrex Bioscience, Walkersville, MD
Developed 18 P&ID’s for the 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, Greenville, SC
Designed & developed bid packages for filtration, ultrafiltration, diafiltration, CIP & chromatography skids. bioMerieux, Durham, NC, Talecris Biotherapeutics, 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 with 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 with 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, Medimmune, Frederick, MD, Novartis - OTC, Lincoln, NE, Pfizer, Terre Haute, IN, Protein Design Labs, Plymouth, MN, Novartis - OTC, Lincoln, NE, Pfizer, Terre Haute, IN
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 the same. Argos Therapeutics, Durham, NC
Site Evaluation / Process Development / Design. Greer Labs, Lenoir, NC, bioMerieux, Durham, NC
Site Evaluation / Review / Turn Over Package (TOP) Development for CIP, Compressed Air, Nitrogen, HVAC, Boiler and Electrical Systems. Pearl Therapeutics, Durham, NC
Performed pre start up review of new surfactant / Polyvinylpyrrolidone (PVP/PVPi) pharmaceutical / excipients plant. BASF, Geismar, LA
Process Safety Management – PSM for epoxy, def...
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