NNE Pharmaplan
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NNE Pharmaplan Employees
NNE Pharmaplan July 2014 - Present
Amgen June 2010 - June 2014
Amgen July 2006 - June 2010
Biolex February 2006 - July 2006
Wyeth Vaccines August 2003 - February 2006
Bayer Biological Products June 2001 - August 2003
Rohm and Haas 2000 - 2001
Skills
Validation, Technology Transfer, Process Simulation, Chromatography, Process Engineering, Purification, Plant Design, Equipment Commissioning, Process Automation, Project Management, Process Piping Design, P&ID, GAMP, UF/DF, CIP, SIP, Clean Utilities, Cross-functional Team..., PI Data Historian, Filtration, Process Optimization, Process Monitoring, Six Sigma, Lean Manufacturing, Debottlenecking, Change Control, Cleaning Validation, Emerson DeltaV, Start-ups, Biopharmaceuticals
Education
North Carolina State University 1994 — 2000
BS, Chemical Engineering
ACIES Engineering July 2015 - Present
Lighthouse Engineering July 2012 - April 2015
NNE Pharmaplan October 2011 - July 2012
Three Sixty Engineering May 2010 - April 2011
Jordan, Jones and Goulding June 2007 - August 2008
Shepherd Harvey and Associates January 2003 - June 2007
Barrett Woodyard & Associates March 2001 - December 2002
Skills
AutoCAD, Carrier HAP, Facilities Management, Engineering, Plumbing, MS Project, Renovation, Elite HVAC software, Word, Excel, Microsoft Project, HVAC, Construction, CAD, Piping
Education
Rochester Institute of Technology 1988 — 1991
Bachelors, Mechanical Engineering Technology
NNE Pharmaplan January 2014 - Present
Institute of Bioengineering and Nanotechnology Singapore June 2012 - November 2012
The University of British Columbia July 2010 - February 2011
Skills
Molecular Biology, Biochemistry, Cell Culture, Lifesciences, Cell Biology, Western Blotting, Biotechnology, Genetics, Protein Purification, Science, PCR primer design, PCR, Fermentation, English, MS Office
Education
IMC Fachhochschule Krems 2011 — 2013
Master of Science in Engineering MSc, Medical and Pharmaceutical Biotechnology, 1,0
IMC Fachhochschule Krems 2008 — 2011
Bachelor of Science in Engineering, Medical and Pharmaceutical Biotechnology, 1,40
NNE Pharmaplan May 2013 - Present
Triangle Certification, LLC March 2010 - April 2013
Specialty Testing, Inc February 2007 - March 2010
Contamination Control Technologies, Inc 2000 - 2006
Skills
Validation, GMP, GAMP, 21 CFR Part 11, English, Team Building, HVAC Controls, FDA GMP, Aseptic Processing, Change Control, Microsoft Excel, Windows, Research, Spanish, Performance Testing, SOP development, V&V, FDA, Biotechnology, GxP, CAPA, Biopharmaceuticals, Teaching, System Testing, LIMS, Vaccines, GLP, Environmental Monitoring, SOP, Microsoft Word, Certifications, Pharmaceutical Industry, Quality Assurance, Quality System, Project Management
Education
Durham Technical Community College 2007 — 2008
Biotechnology
Universidad de Guadalajara 1990 — 1992
Associate of Arts (A.A.), English Language and Literature/Letters
National Environmental Balancing Bureau
NEBB Certified CPT
Kennedy Strategic Consulting 2014 - Present
ISPE Boston Area Chapter August 2015 - Present
NNE Pharmaplan 2014 - 2014
M+W Group January 2011 - December 2013
Xcellerex January 2010 - December 2010
Parsons 2002 - 2010
Vanderweil Engineers 1997 - 2002
NBTY, Inc. 1995 - 1997
Cutler Associates 1992 - 1995
Suffolk Construction Company Inc. 1990 - 1992
Skills
Strategy, Strategic Planning, Start-ups, Management, Analysis, Mergers & Acquisitions, Business Development, New Business Development, Project Management, Program Management, Contract Negotiation, Project Planning, Engineering, Process Engineering, Procurement, High Performance Teams, Leadership, Pharmaceutical Industry, Biotechnology, Biopharmaceuticals, Manufacturing, Construction, 21 CFR Part 11, GMP, Validation, Sop, Six Sigma, Quality Assurance, SOP
Education
Boston University
Certificate of Project Management
Syracuse University 1978 — 1981
North Carolina State University 1977 — 1978
West Springfield High School 1975 — 1977
International School Bangkok 1973 — 1975
Novartis Vaccines August 2010 - Present
PRO Unlimited March 2009 - August 2010
NNE Pharmaplan June 2007 - September 2008
Covidien May 2005 - June 2007
Skills
Validation, cGMP practices, Microsoft Office, Kaye Validator, Pharmaceutical Industry, 21 CFR Part 11, Computer System..., Change Control, GMP, Quality System, Aseptic Processing, LIMS, FDA, Sop, GxP, V&V, Trackwise, CAPA, Cleaning Validation, Sterilization, GLP, USP, Equipment Qualification, Deviations, Technology Transfer, Regulatory Requirements, GAMP, FDA GMP, Biopharmaceuticals, Vaccines, cGMP manufacturing
Education
Campbell University 2002 — 2005
Bachelor of Science (BS), Pharmaceutical Sciences
NNE Pharmaplan May 2013 - Present
Amgen June 2010 - May 2013
St. Jude Medical July 2008 - June 2010
Covidien August 2004 - July 2008
Skills
Solidworks, Design Control, Mechanical Engineering, Lean Manufacturing, FMEA, Pro Engineer, Minitab, Six Sigma, R&D, Manufacturing, Design of Experiments, CAD, DFMEA, FDA, Product Development, Engineering, Matlab, Medical Devices, Validation, Product Design, Testing, Root Cause Analysis, Plastics, ISO 13485, Manufacturing..., CAPA, Strategic Planning, Engineering Management, GMP, Cross-functional Team..., New Product..., Machining, V&V, Project Engineering, GD&T, Design for Manufacturing, Quality System, Injection Molding, ISO 14971, SPC, DMAIC, Drug Delivery, Biomedical Engineering, ISO, Process Engineering, Process Simulation, Value Stream Mapping, Supplier Quality, Change Control, Kaizen
Education
Illinois Institute of Technology 2004 — 2006
MS, Mechanical and Aerospace Engineering
Sardar Patel University 1999 — 2003
BS, Mechanical Engineering
NNE Pharmaplan November 2011 - Present
NNE Pharmaplan January 2010 - October 2011
NNE Pharmaplan March 2007 - January 2010
Novo Nordisk 2004 - 2007
Novo Nordisk 2000 - 2003
Novo Nordisk 1998 - 2000
Ulfoss Plastic A/S 1995 - 1998
MT Group 1994 - 1995
MT Group 1992 - 1994
Skills
Pharmaceutical Industry, FDA, Validation, GMP
Education
INSEAD 2009 — 2009
IEP, International Executive Program
INSEAD 2006 — 2006
IPM, International Project Management
Novo Nordisk 2001 — 2003
SMA, Supply Manager Academy
Engineering College of Haslev 1989 — 1992
BSc, Mechnical Engineering
Fitbay.com September 2013 - Present
Creandum September 2013 - February 2014
Vivino December 2012 - August 2013
Creandum August 2012 - August 2013
McKinsey & Company August 2008 - August 2012
Unibar.dk August 2006 - July 2007
NNE Pharmaplan June 2006 - August 2006
McKinsey & Company June 2005 - August 2005
J.P. Morgan January 2005 - March 2005
Skills
Venture Capital, Internet, Start-ups, Entrepreneurship, Social Networking, Business Strategy, Engineering, Business Case, Due Diligence, E-commerce, Project Management, Corporate Development, Strategy, Investments, Management Consulting, Financial Modeling, Business Development, Product Management
Education
Harvard University 2007 — 2008
M.S., Engineering Sciences
Dartmouth College 2002 — 2006
B.A., Engineering Sciences with Honors
Copenhagen International School 1989 — 2002
International Baccalaureate
NNE Pharmaplan November 2014 - Present
Merck February 2014 - October 2014
Merck August 2012 - February 2014
Merck August 2010 - July 2012
Skills
FDA, Technology Transfer, CAPA, Validation, GMP, Change Control, Aseptic Processing, Process Simulation, Design of Experiments, Sop, Biopharmaceuticals, GAMP, 21 CFR Part 11, Quality by Design, Process Engineering, Six Sigma, SOP
Education
Lehigh University 2011 — 2013
Master of Engineering (M.Eng.), Biological Chemical Engineering
Carnegie Mellon University 2006 — 2010
Bachelor of Science (B.S.), Chemical Engineering and Biomedical Engineering
Sabra Dipping Company, LLC March 2013 - Present
NNE Pharmaplan October 2011 - March 2013
Micron Technology May 2011 - October 2011
Boehringer Ingelheim Chemicals May 2008 - January 2011
Skills
Chemical Engineering, Commissioning, Process Engineering, Validation, Manufacturing, Quality Management, Automation, Troubleshooting, Engineering, Process Automation, Six Sigma, Process Control, Process Improvement, Continuous Improvement, GMP, Cross-functional Team...
Education
Virginia Polytechnic Institute and State University 2007 — 2011
BS, Chemical Engineering
Technical University of Denmark 2010 — 2010
NNE Pharmaplan July 2014 - Present
M+W Group January 2010 - May 2014
Parsons 2003 - 2010
Jacobs 1997 - 2003
Life Sciences International 1990 - 1997
Fluor Corporation 1987 - 1990
Biocraft Laboratories, Inc. 1987 - 1989
Skills
Process Engineering, Biopharmaceuticals, Commissioning, Project Management, Project Planning, Construction, Validation, BIM, Simulations, LEED, Containment, Isolators, Designs
Education
New Jersey Institute of Technology
Master of Science (MS), Chemical Engineering
NNE Pharmaplan July 2011 - June 2012
ISPE Boston Area Chapter International Society of Pharmaceutical Engineering 1992 - 2011
PAREXEL Consulting February 2008 - May 2010
Strategic BioSolutions September 2004 - June 2007
Formatech July 2003 - June 2004
BioMetics January 1994 - February 1998
Skills
Biotechnology, GMP, Pharmaceutical Industry, Vaccines, V&V, Medical Devices, Protein Chemistry, Clinical Trials, Product Development, Strategy, Business Development, Formulation, Pharmaceutics, Monoclonal Antibodies, FDA, Technology Transfer, Biopharmaceuticals
Education
Babson College
Masters of Business Administration, Finance, Marketing
Emma Willard
Emma Willard
University of Vermont
BS, Medical Technology
Petitte Engineering June 2014 - Present
Corbion September 2012 - Present
NNE Pharmaplan August 2012 - June 2014
LabGeisha February 2013 - May 2014
DiscoverLit February 2011 - March 2012
NC State University August 2010 - May 2011
North Carolina State University August 2009 - May 2011
North Carolina State University January 2010 - March 2010
Novozymes May 2009 - August 2009
MedImmune June 2008 - August 2008
Skills
Biotechnology, Cell Culture, Chemical Engineering, Fermentation, Lifesciences, PCR, Purification, SDS-PAGE, Polymers, Ruby, Ruby on Rails, JavaScript, jQuery, HTML, CSS, AJAX, Biopolymer Production, Strategic Technology..., Pilot Projects, Scale Up, Node.js, AngularJS, MongoDB, TypeScript
Education
North Carolina State University 2006 — 2011
B.S. Biomolecular Engineering, B.S. Biochemistry, Minor Biotechnology
Sophia University 2010 — 2010
Novartis Institute for Biomedical Research - Biocamp 2009 2009 — 2009
Businesses in Biotechnology
Premier Project Management, LLC May 2007 - Present
US NItrogen LLC February 2014 - Present
Premier Project Management, LLC September 2013 - March 2014
Faithful+Gould January 2013 - September 2013
NatureWorks LLC July 2011 - March 2013
NNE Pharmaplan May 2010 - July 2011
ADM October 2009 - April 2010
Florida Power & Light March 2009 - August 2009
Midwest Ethanol Producers, LLC March 2005 - March 2009
Power and Industrial Services of Wisconsin August 2001 - March 2005
Skills
AutoCAD, MS Project, Welding, Project Coordination, Construction Project..., OSHA 30 Hour, Metal Fabrication, Primavera P6, Construction Ma, Project Management, HAZWOPER, CPM Scheduling, Construction Planning, Weld, Construction, Construction Management, Schedule Control, Scope Planning, Risk Management Plans, Safety Monitoring, Integrated Master..., Value Engineering, Change Orders, Scopes Of Work, Field Coordination, Field Supervision, OSHA 30-Hour, Change Order Negotiation, Construction Document..., Construction Site..., Power Plants, Commissioning, EPC, Petrochemical, Piping, Procurement, Factory, Contractors, Project Planning, Project Engineering, Engineering, Quality Assurance, Project Control, Contract Negotiation, Construction Safety, Electricians, Materials, Project Estimation, Cost Control, Subcontracting
Education
University of Phoenix 2012 — 2013
Certification, Project Management
University of Phoenix 2009 — 2011
BA, Business Management
Portland Community College 1996 — 1998
Associate's degree, Fire Science
Oregon State 1994 — 1996
Clackamas Community College 1993 — 1996
AS, Fire Science
Mt. Hood Community College 1993 — 1996
AS, Manufacturing Technology
NNE Pharmaplan November 2013 - Present
Extrinsic January 2013 - November 2013
Aerotek Engineering February 2011 - January 2013
Verizon Wireless April 2009 - February 2011
Wachovia Dealer Services September 2008 - March 2009
Parker Reality Group July 2007 - July 2008
Skills
Technical Recruiting, Sales, Recruiting, Management, Internet Recruiting, HR Consulting, CRM, Talent Acquisition, SAP, IT Recruitment, Business Development, Account Management, Applicant Tracking..., Staffing Services, ERP, Contract Recruitment, Sourcing, Project Management, Temporary Placement, Personal Recruiting, LinkedIn, Screening Resumes, Networking, SAP R/3, Training, Proposal Writing, Microsoft Office, Sales Proposals, Sales Process, Sales Management, Negotiation, Sales Presentations, Sales Strategy, Technical Sales..., Pharmaceutical Industry, Strategic Sales, MES, Biotechnology, Life Sciences, Proposal Management, Solution Selling, Strategic Thinking, Salesforce.com, Key Account Management, Lead Generation, Budgets, Trade Shows
Education
East Carolina University 2004 — 2008
Bachlors Degree
North Carolina Real Estate Comission 2007 — 2007
North Carolina Real Estate agent
Sandler Sales Training
Drexel University ISSS August 2014 - Present
The Estée Lauder Companies Inc March 2015 - September 2015
Sinopharm Group Company Limited April 2014 - September 2014
Arkema ,Sartomer Buiness Unit April 2013 - September 2013
Drexel University September 2012 - March 2013
NNE Pharmaplan July 2012 - August 2012
Skills
Chemical Engineering, Matlab, Aspen HYSYS, Chemistry, Process Engineering, Engineering, AutoCAD, Materials Science, Process Simulation, Microsoft Office, Polymers, Thermodynamics, Maple, Design of Experiments, Microstation, SAP, Lean Manufacturing, Gemba, Six Sigma, Data Analysis
Education
Drexel University 2011 — 2016
Bachelor of Science (BS), Chemical Engineering
NNE Pharmaplan July 2014 - Present
Environmental AAir Systems LLC October 2008 - July 2014
Environmental Air Systems LLC. November 2004 - October 2008
EAS March 1998 - November 2004
Skills
Project Coordination, Revit Mechanical, Navisworks, BIM, Revit, AutoCAD, Construction, QuickPen Pipe, QuickPen Ductdesigner, Plumbing, MEP, Construction Drawings, Virtual Design, HVAC, Microstation, MEP Coordination, AutoCAD Mechanical, Integrated Project..., Submittals, Project Estimation, Mechanical Engineering, Autodesk Software, Electricians, Piping, Mechanical Drawings, SketchUp, Microsoft Office, Engineering, CAD, 3D
Education
Danville Community College 1989 — 1991
COLLEGE DIPLOMA, DRAFTING AND DESIGN
Hayes Automation, LLC February 2015 - Present
Oxford Global Resources December 2014 - January 2015
Oxford Global Resources December 2013 - June 2014
SpecLine Consulting, Inc. April 2013 - June 2013
Zenith Technologies February 2011 - August 2012
PharmaServ, Inc. September 2009 - February 2011
Aqueous Systems, Inc November 2007 - March 2009
NNE Pharmaplan October 2003 - November 2007
CDI Professional Services June 2003 - October 2003
CRB Consulting Engineers May 1997 - May 2003
Skills
Automation, Integration, Control Systems Design, Process Control, PLC Programming, SCADA, Control Logic, Process Automation, Software Development..., Software Development, Batch Control, 21 CFR Part 11, GAMP, GMP, Software Documentation, P&ID, Change Control, Software Implementation, Commissioning, Technical Documentation, Document Drafting, Document Review, cGMP practices, Customer Support, Purified Water, Instrumentation, Process Equipment, PLC, Allen Bradley, HMIs, Human Machine Interface, Troubleshooting, Pharmaceutical Industry, Computer System..., Project Engineering, Validation, MES, DCS, V&V, Wonderware, RSLogix, Emerson DeltaV
Education
Grantham University 1993 — 1995
Associate of Science (AS), Engineering Technology, General
Community College of the Air Force 1990 — 1991
Associate of Science (AS), Avionics Guidance and Control
TriMedx December 2014 - Present
Massachusetts Institute of Technology (MIT) May 2014 - October 2014
Massachusetts General Hospital January 2014 - May 2014
University Health Network September 2012 - December 2013
Canadian Forces November 2007 - November 2013
NNE Pharmaplan July 2012 - August 2012
Hologic - Sentinelle Medical Division August 2010 - July 2011
Skills
C, C++, Matlab, AutoCAD, Solidworks, Microsoft Office, Problem Solving, Research, Product Development, Process Engineering, Manufacturing, Customer Service, Medical Devices, Biotechnology, Troubleshooting, Lean Manufacturing, Microsoft Excel, Biomedical Engineering, Science, Engineering, Hospitals
Education
University of Toronto 2012 — 2014
Master of Health Science (M.H.Sc), Clinical Engineering, A
University of Toronto 2007 — 2012
Bachelor of Applied Science (B.A.Sc.), Engineering Science Major in Biomedical Engineering
Harvard University
Engineering Sciences - Microfluidics, A
NNE Pharmaplan August 2014 - Present
North Carolina State University August 2013 - May 2014
Wyrick Robbins Yates & Ponton LLP August 2012 - February 2013
Education
North Carolina State University 2010 — 2014
Chemical Engineering, Biomanufacturing Sciences
Columbia University in the City of New York August 2015 - Present
FreshDirect September 2014 - May 2015
QVARTZ January 2014 - July 2014
NNE Pharmaplan February 2014 - May 2014
Aller Media A/S November 2013 - January 2014
Procter & Gamble July 2013 - September 2013
Danfoss February 2013 - June 2013
Netbriller.com December 2010 - June 2011
Bøger & Papir November 2009 - January 2010
Kalundborg Hallerne August 2009 - January 2010
Skills
Danish, English, German, Microsoft Excel, Prezi, CRM, Market Analysis, Analysis, Innovation Management, Business Strategy, Project Management, Project Planning, Statistics, Mathematics, Economics, Strategy, Management, Microsoft Office, Management Consulting, Financial Modeling, Presentations
Education
Columbia University in the City of New York 2014 — 2015
Master’s Degree, Management Science and Engineering (MS&E), CGPA 3.998/4
Technical University of Denmark 2010 — 2014
Bachelor's degree, Global Business Engineering, 11.4 (= 3.9 of 4 GPA)
Stanford University 2012 — 2012
Study Abroad, Mangement & Engineering Science, A+ , A- & Pass
University of California, Los Angeles 2012 — 2012
Visiting student, Engineering and management, A+ , A+ & A
Kalundborg Gymnasium 2006 — 2009
STX, English A, Math A, Politics and Society B, 10.2 (3.5 of 4 GPA)
Zenith Technologies February 2014 - Present
NNE Pharmaplan February 2012 - January 2014
Proconex June 2008 - January 2012
Skills
Automation, Emerson DeltaV, Batch Control, cGMP practices, cGMP manufacturing, GAMP, S88, VMware, Change Control, GMP, FDA, Process Automation, Commissioning, Testing, Computer System..., Batch Processing
Education
Penn State University 2002 — 2008
Bachelor of Science (BS), Chemical Engineering
Genentech January 2009 - Present
NNE Pharmaplan July 2008 - December 2008
Novo Nordisk Delivery Technologies 2005 - June 2008
Nektar Therapeutics 1998 - 2004
Inhale Therapeutics 1998 - 2004
ALZA Corporation 1995 - 1997
Amgen Inc. 1990 - 1995
Fluor Daniel 1987 - 1990
United States Borax and Chemical Corp 1981 - 1987
Skills
FDA, Pharmaceutical Industry, Supply Chain Management, GMP, Manufacturing, Validation, Biotechnology, Process Improvement, Quality System, Supply Chain, Contract Negotiation, Contract Management, V&V, Technology Transfer, CAPA, Purchasing, Biopharmaceuticals, Vendor Management, Negotiation, Materials Management, Continuous Improvement, Management, Drug Development, Change Control, Engineering, Process Engineering, ISO 13485, Quality Assurance
Education
California State University-Fullerton
Bio Chemistry
University of Redlands
BS, Business Administration/Life Science
NNE Pharmaplan July 2014 - Present
Parsons June 2004 - July 2014
Process Facilities, Inc. February 1998 - June 2004
Raytheon Engineers and Constructors (formerly Badger Engineers) July 1981 - February 1998
Skills
Construction, Contract Management, Construction Management, Engineering, Process Engineering, MS Project, Project Management, Project Engineering, Earned Value Management, Project Planning, Engineering Management, P&ID, Primavera P6, Project Control, Piping, Procurement, Value Engineering, Project Coordination
Education
Columbia University - Columbia Business School 1979 — 1981
MBA, Finance
Tufts University 1973 — 1977
BS, Chemical Engineering
NNIT September 2011 - January 2015
NNE Pharmaplan January 2008 - August 2011
NNE Pharmaplan A/S August 2007 - December 2007
NNE Pharmaplan December 2006 - July 2007
Tycho Brahe Planetarium 2000 - 2005
Skills
Project Management, Project Portfolio..., Change Management, Software Documentation, Project Planning, Quality Assurance, SharePoint, Validation
Education
Københavns Universitet 1997 — 2006
Cand.scient., Mathematics and Chinese
Stenhus Gymnasium 1993 — 1995
C&S Wholesale Grocers April 2014 - Present
C&S Wholesale Grocers August 2013 - April 2014
Smiths Medical October 2011 - May 2013
NNE Pharmaplan March 2010 - October 2011
International Society for Pharmaceutical Engineers 1997 - 2011
Covidien April 2007 - March 2010
Novartis March 2000 - April 2007
Commissioning Agents, Inc October 1997 - March 2000
Performance Validation October 1995 - October 1997
US Navy October 1989 - October 1995
Skills
Safety Management..., FDA GMP, Operations Management, Program Management, Project Management, Operational Excellence, Lean Thinking, Change Management, Development & delivery..., Pharmaceutical Industry, Medical Devices, GMP, FDA, Six Sigma, Process Improvement, Lean Manufacturing, Cross-functional Team..., Training, Engineering, Software Documentation, CAPA, Root Cause Analysis, Value Stream Mapping, Quality System, Continuous Improvement, ISO 13485, Validation, Management, Manufacturing, V&V, 21 CFR Part 11, Quality Assurance, DMAIC, Leadership, ISO, Design of Experiments, Change Control, Quality Management, Computer System..., Product Development, Quality Control, Sop, Design Control, Process Engineering, Biotechnology, R&D, Quality Auditing, SPC, Technology Transfer, Process Simulation
Education
The University of Connecticut School of Business 2004 — 2006
Masters, MBA
Thomas Edison State College 2003 — 2004
BS, Nuclear Engineering
Southern Illinois University, Carbondale 2001 — 2004
BS AST, Workforce Education, Training, and Development
NNE Pharmaplan June 2006 - Present
Croxton Gray Commercial Properties May 2006 - December 2009
Fluor Corporation 1996 - 2006
Education
Clemson University 1991 — 1996
NNE Pharmaplan 2014 - Present
NNE Pharmaplan US 2010 - Present
ISA-88 and IEC-61512 Batch Control 2001 - Present
Maverick Technologies 2006 - 2009
Maverick Technologies May 2007 - December 2008
Invensys 2001 - 2005
Invensys 2000 - 2001
International Specialty Products 1992 - 2000
Pfizer 1989 - 1992
Skills
Process Control, DCS, Project Management, Automation, PLC, MES, Consulting, Functional Decomposition, Workflow Diagrams, Batch Control, S88, GAMP, Technical Leadership, Front End Engineering..., Control Logic, Model Predictive Control, Operational Excellence, DMAIC, Commissioning, Standards Development, Engineering, Six Sigma, Validation, Integration, Manufacturing, SCADA, Instrumentation
Education
Princeton University
BS, Chemical Engineering & Engineering Physics
Rensselaer Polytechnic Institute
MS, Advanced Control & Optimization
Quality Compliance Partners September 2013 - Present
Validation/Regulatory Professional 2007 - Present
PAREXEL September 2013 - May 2015
Sanofi Pasteur Ltd. September 2013 - May 2015
NNE Pharmaplan 2015 - 2015
NNE Pharmaplan 2015 - 2015
NNE Pharmaplan 2015 - 2015
NNE Pharmaplan 2015 - 2015
Regeneron June 2011 - September 2013
Bristol-Myers Squibb October 2009 - April 2010
Skills
Validation, GMP, Change Control, V&V, Sop, Computer System..., Cleaning Validation, Analytical Chemistry, FDA, Quality Assurance, Aseptic Processing, 21 CFR Part 11, GAMP, Pharmaceutical Industry, Medical Devices, Biotechnology, Commissioning, Testing, GxP, Technology Transfer, Biopharmaceuticals, Quality Auditing, Quality System, CAPA, GLP, Microbiology, Software Documentation, Sterilization, CIP, Regulatory Affairs, Quality Management, Change Management, Manufacturing, Technical Writing, Lifesciences, Management, Regulatory Requirements, Risk Assessment, Document Management, Process Simulation, Start-ups, Business Development, Auditing, Packaging, Quality Systems, Life Sciences, Consent Decree..., LIMS, SOP
Education
Keene State College 1980 — 1984
BS, Bio-Chem
Biothermal LLC October 2010 - Present
Biothermal LLC 2003 - Present
Hospira 2010 - 2011
Sandoz 2009 - 2009
NNE Pharmaplan 2008 - 2008
Organon Technika 2008 - 2008
MedImmune 2007 - 2007
Valsource 2003 - 2005
Diosynth Biotechnology 2002 - 2003
Diosynth 2000 - 2003
Skills
Quality Control, Change Control, Technology Transfer, Biotechnology, CAPA, Lifesciences, Quality System, Sop, Management, Lean Manufacturing, Manufacturing, Validation, Pharmaceutical Industry, FDA, Leadership, Quality Assurance, GMP, V&V, Six Sigma, Computer System..., 21 CFR Part 11, Regulatory Affairs, GxP, ISO 13485
Education
Kennedy Western University 2004 — 2008
Bachelor of Science, Engineering: Mechanical
Frankel Staffing Partners March 2015 - Present
NNE Pharmaplan June 2013 - August 2014
NNE Pharmaplan April 2013 - June 2013
TeamHealth July 2012 - April 2013
Saguaro Management & Accounting Services August 2010 - July 2012
Saguaro Management & Accounting Services February 2008 - August 2010
Skills
Payroll, Employee Benefits, Human Resources, Account Reconciliation, Payroll Taxes, Accounting, Customer Service, Microsoft Excel, Accounts Receivable, ADP ezLaborManager, ADP E-Time, Microsoft Navision, Garnishments, Outlook, Management, Technical Writing, SOP development, Text Editing, Photoshop, Lawson HRIS, Sage Abra HRMS, Sage MAS200, Invoicing, A/R collections, ADP Payroll, Microsoft Word, Team Building, Bank Reconciliation, Project Accounting, Microsoft Office
Education
North Carolina Wesleyan College 2010 — 2013
Bachelor of Science (BS), Business Administration
NNE Pharmaplan October 2014 - Present
NNE Pharmaplan August 2005 - October 2014
Education
North Carolina State University 2000 — 2004
Bachelor of Science (BSc), Business Administration, Management and Operations
Williamson Consulting inc. April 2015 - Present
Kedrion Biopharma Inc. November 2014 - May 2015
Sanofi April 2014 - November 2014
Oso BioPharmaceuticals Manufacturing, LLC February 2014 - March 2014
VolPal October 2013 - December 2013
NNE Pharmaplan January 2013 - October 2013
Aveva Drug Delivery Systems An Apotex Company May 2012 - February 2013
B. Braun Medical/(CAPS) Central Admixture Pharmacy Services Inc October 2011 - June 2012
Vetter Development Services USA August 2010 - November 2011
Sentry Manufacturing, Inc April 2010 - July 2010
Skills
Pharmaceutical Industry, GMP, Validation, Cleaning Validation, Biotechnology, Analytical Chemistry, Medical Devices, FDA, Sop, Microbiology, V&V, Quality Assurance, Quality System, Aseptic Processing, CAPA, Change Control, Quality Control, Laboratory, GLP, Pharmaceutics, Life Sciences, SOP
Education
Concordia University-River Forest 2011 — 2013
MBA
Concordia University, Nebraska 1999 — 2004
Bachlers degree, Biology, Geogrphy
PAREXEL December 2012 - Present
Coty June 2011 - December 2012
NNE Pharmaplan May 2010 - August 2010
RTI International October 2008 - May 2010
Wyeth Pharmaceuticals September 2004 - October 2008
Wyeth Pharmaceuticals July 2002 - September 2004
Wyeth Pharmaceuticals September 2000 - July 2002
Wyeth Pharmaceuticals July 1999 - September 2000
Gold Kist, Inc April 1995 - July 1999
Skills
Project Finance, Financial Analysis, Budgeting, Budgets, Financial Reporting, SAP, Accounting, Forecasting, Project Planning, Auditing, Project Management, Managerial Finance, Hyperion Enterprise, MS Project, Management, Outlook
Education
Strayer University 2007 — 2009
MBA, Masters of Business Administration - Management
Campbell University 2000 — 2004
BA, Bachelors in Business Administration
Patheon June 2015 - Present
Patheon (formerly DSM Pharmacueticals) June 2012 - June 2015
NNE Pharmaplan May 2010 - June 2012
Fresenius Kabi USA (Parent company of APP Pharmaceuticals) November 2009 - May 2010
Catalent Pharma Solutions (formerly Cardinal Health) October 2006 - November 2009
DSM June 2002 - October 2006
Skills
Validation, Technology Transfer, Process Validation, Aseptic Processing, cGMP, Manufacturing, SOP, Pharmaceuticals, V&V, GMP, Sop, Pharmaceutical Industry, CAPA, Batch Records, Deviation Management, Change Control, FDA, Quality System, Formulation, Quality Control, Sterilization, Design of Experiments, Lyophilization, 21 CFR Part 11, Vaccines, Biopharmaceuticals, LIMS, GxP, GLP, Cleaning Validation, Computer System..., HPLC, Biotechnology, Regulatory Affairs, Purification, Analytical Chemistry
Education
East Carolina University 2011 — 2013
Master of Science - Technology Systems (Concentration in Manufacturing Systems)
East Carolina University 1998 — 2002
Bachelor's Degree, Biology, Biotechnology and Molecular Biology, Magna Cum Laude
East Carolina University 1998 — 2002
Bachelor's Degree, Philosophy, Magna Cum Laude
Indiana State University
TU Wien July 2008 - Present
M & W Group December 2006 - June 2008
Lonza 2004 - 2007
NNE Pharmaplan 2002 - 2004
EPFL 1997 - 2001
EPFL (Swiss Federal Institute of Technology Lausanne) 1997 - 2001
Skills
Technology Transfer, Biotechnology, GMP, Fermentation, Bioprocessing, Biochemical Engineering, Lifesciences, Pharmaceutical Industry, Downstream Processing, Life Sciences, Biochemistry, R&D, Biopharmaceuticals, Validation, Process Simulation, Purification
Education
1997 — 2001
PhD, Bioprocess Engineering
RWTH Aachen University 1989 — 1994
Diplom Ingenieur, Master, Mechanical & Process Engineering
CHG 1979 — 1988
Baccalaurat
Bodhi Path December 2012 - Present
Finanstilsynet / Danish Financial Supervisory Authority (FSA) August 2008 - December 2012
NNE Pharmaplan February 2002 - January 2008
PCSYS A/S 2001 - 2002
Supply Services A/S 2000 - 2001
Danish Agency for Science, Technology and Innovation 1999 - 2000
The Science Shop , Faculty of Science, University of Copenhagen 1995 - 1999
The Science Shop , Faculty of Science, University of Copenhagen 1990 - 1995
Skills
Risk Management, Change Management, Analysis, Project Management, Project Planning, Coaching, Process Improvement, Governance, Business Strategy, Risk Assessment, Team Leadership, Business Analysis, Financial Risk, Auditing, Team Building, Management, Quality Assurance, Security, IT Management, Strategy, IT Strategy, ITIL
Education
Københavns Universitet / University of Copenhagen 1987 — 1995
B.sc, Computer Science
Rødovre statsgymnasium 1985 — 1987
Student, Matematik - fysik
Holmegårds skolen
Duke Energy Progress (Carolinas East) June 2008 - Present
NNE Pharmaplan 2006 - 2008
NNE Pharmaplan US 2006 - 2008
Talecris 2001 - 2006
Bayer Biological Products 2001 - 2006
Bayer HealthCare September 2001 - April 2005
Corestaff at Caterpillar 2000 - 2001
North Carolina State University January 1998 - November 1999
US EPA May 1998 - August 1998
Hudson Belk Dept Store / Raleigh, NC 1993 - 1996
Skills
MS Project, Software Documentation, Microsoft Excel, Project Management, Data Analysis, Program Management, Access, Microsoft Office, Project Planning, Visio, Change Management, Process Improvement, SAP, Quality Management, Quality Assurance, Oracle, Management, 21 CFR Part 11, Team Building, Leadership, Six Sigma, Troubleshooting, Process Engineering, Analysis, Testing, Vendor Management, Cross-functional Team..., PMP, Engineering, Change Control, Project Portfolio..., SharePoint, Contract Management, Risk Management, Integration, Business Process..., Business Analysis, Process Simulation, SDLC, Requirements Analysis, Energy, PMO, Nuclear, Team Leadership, Continuous Improvement, Technical Writing, Earned Value Management, Computer System..., Project Coordination
Education
North Carolina State University 1995 — 2002
Bachelor of Science in Meteorology, Meteorology
Clayton High School 1991 — 1995
Clayton High School 1991 — 1995
High School Diploma, Advanced Placement and Honors
NNE Pharmaplan July 2012 - Present
Novartis Vaccines and Diagnostics June 2011 - July 2012
BTEC Biomanufacturing Training Education Center May 2011 - December 2011
NCSU August 2010 - December 2011
Vision Contractors Incorporated December 2008 - June 2009
Skills
Fermentation, Cell Culture, Biotechnology, Aseptic Processing, Matlab, Engineering, Quality Assurance, AutoCAD, Bioreactor, GMP, SDS-PAGE, Chromatography, Laboratory, Purification
Education
North Carolina State University 2011 — 2014
Master's degree, Chemical Engineering- Biomanufacturing
NCSU 2007 — 2011
BS, Biological Engineering
North Carolina State University 2006 — 2011
Biological Engineering, Biological Processes, Environmental/Ecology Protection, Biomanufacturing
NNE Pharmaplan December 2014 - Present
NNE Pharmaplan April 2014 - December 2014
NNE Pharmaplan June 2011 - April 2014
NNE Pharmaplan October 2009 - July 2011
Bay-Tec Engineering / Emerson Process Management April 2008 - October 2009
Rockwell Automation June 2006 - April 2008
Rockwell Automation January 1996 - June 2006
Skills
Pharmaceutics, PLC, Automation, Integration, Computer System..., Program Management, Engineering, Biotechnology, Budgets, Process Automation, Medical Devices, Process Control, Validation, Business Development, Electronics, FDA, Lean Manufacturing, Pharmaceutical Industry, Quality Assurance, Biopharmaceuticals, Project Management, Manufacturing, GMP, MES, Process Engineering, Management, Commissioning, ERP, Six Sigma, SCADA, Testing, Instrumentation, Process Optimization, Process Simulation
Education
Case Western Reserve University 1992 — 1997
BSEE, Electrical Engineering & Applied Physics
NNE Pharmaplan September 2012 - Present
NNE Pharmaplan June 2005 - September 2012
Skills
Computer System..., Biotechnology, Engineering, CAPA, Instrumentation, PLC, Validation, Project Engineering, GAMP, V&V, Automation, DCS, Process Control, SCADA, Project Management, Process Automation, GMP, Change Control, Commissioning, Pharmaceutical Industry, 21 CFR Part 11, GxP
Education
North Carolina State University 1986 — 1994
BS, Electrical Engineering
St. Joseph Health May 2009 - Present
NNE Pharmaplan September 2007 - August 2008
Manex/CMTC & Independent Contractor 1998 - 2007
Various Consumer Products Companies 1983 - 1997
Skills
Lean Manufacturing, Six Sigma, Change Management, Medical Devices, Healthcare, Business Services, Pharmaceutics, Industrial Sector, Airlines, Operational Excellence, Continuous Improvement, Process Improvement, Value Stream Mapping, Quality System, Quality Management, Kaizen, Manufacturing
Education
Southern Polytechnic State University 1993 — 1995
MS, Quality Assurance, Engineering and Technology Concentration
NNE Pharmaplan September 2014 - Present
The Select Group December 2013 - September 2014
Aerotek December 2010 - October 2013
BB&T June 2010 - December 2010
Skills
Customer Service, Management, Inventory Management, Sales, Financial Analysis, Microsoft Office, Time Management, Cold Calling, Outlook, Account Management, Microsoft Word, Teamwork, Team Building, Recruiting, Leadership, Human Resources, Sourcing, Training, Employee Relations
Education
East Carolina University - College of Business 2004 — 2009
BS, Finance
Rebecca & Company Salon July 2011 - Present
Girl Scouts - North Carolina Coastal Pines September 2008 - Present
Tar Heel Machinery March 2012 - July 2013
Johnston County Courthouse September 2011 - October 2012
Harbor, Inc. February 2011 - June 2011
NNE Pharmaplan September 2007 - September 2008
HairColorXperts January 2006 - September 2007
Sport Clips May 2005 - July 2007
Skills
Clerical Skills, Customer Relations, Research, Non-profits, Customer Service, Event Planning, Time Management, Public Speaking, Public Relations, Entrepreneurship, Nonprofits, Child Advocacy, Social Networking, Training, Community Outreach, Data Entry, Sales, QuickBooks, Small Business, Facebook, Blogging, Cosmetology, Interviews, Newsletters, Editing, Teamwork, Volunteer Management, Management
Education
Wayne Community College 2008 — 2010
Associates of Arts - Transfer, Art/Art Studies, General
Central Carolina Community College 2004 — 2005
Diploma, Cosmetology
Johnston Community College 2000 — 2002
Associates, Fine Arts
Genentech September 2015 - Present
Bayside Solutions at DTZ March 2015 - September 2015
NNE Pharmaplan October 2012 - February 2015
Barry-Wehmiller Design Group, Inc. August 2011 - August 2012
Serra February 2010 - August 2011
Nalco Mobotec December 2008 - November 2009
GE Energy December 2007 - November 2008
GE Energy January 2000 - November 2007
Consulting March 2003 - April 2006
Skills
PLC Programming, HMI design, HMI Configuration, HMI Programming, PLC, PLC Allen Bradley, PLC Ladder Logic, System Control, Control Systems Design, SCADA, Allen Bradley, Great Motivator, Peer Relationships, Japanese, Professional..., Gas Turbines, Allen-Bradley
Education
Rensselaer Polytechnic Institute 1993 — 1997
B.S., Aeronautical Engineering
Allegion US May 2014 - Present
Telerent Leasing Corporation 2007 - October 2013
NNE Pharmaplan 2004 - 2007
Universal Weather and Aviation 1988 - 2001
Skills
Microsoft Excel, Microsoft Office, Customer Service, Microsoft Word, PowerPoint, Sales Management, Team Building, Management, Project Management, Sales, Managing Project Budgets, Resource Management, Project Coordination, Account Management, CRM databases, Subcontractor..., Management of Change, DocLink, Invoicing, Cost Control, Epicor, Sales quoting and..., project schedules, Healthcare TV products, Change Management, Salesforce.com, Healthcare
Education
Community College of the Air Force
Meteorology
First Quality Enterprises December 2014 - Present
NNE Pharmaplan December 2009 - November 2014
Merck July 2012 - September 2014
Novo Nordisk A/S March 2010 - June 2012
GlaxoSmithKline June 2007 - June 2009
Teva Pharmaceuticals January 2006 - June 2007
GlaxoSmithKline September 2002 - January 2006
Campbell Soup Company October 2001 - March 2002
Avnet February 1997 - October 2000
TTI, Inc. June 1993 - January 1997
Skills
Quality Assurance, Testing, SharePoint, ITIL, Six Sigma, Validation, ERP, Project Management, GMP, SAP, Manufacturing, Sop, Business Analysis, Software Documentation, Change Management, Computer System..., 21 CFR Part 11, Requirements Gathering, Analysis, Change Control, SDLC, Pharmaceutical Industry, Cross-functional Team..., FDA, GxP, Management, Quality System, Leadership, Strategic Planning, MES
Education
Lehigh University 2007 — 2007
Project Management Certification, Systems Project Management
Drexel University 2000 — 2002
Masters, Information Systems
Clarkson University 1989 — 1993
BS, Marketing/Management
NNE Pharmaplan April 2014 - Present
Ross Deckard Architects October 2013 - November 2014
O'Brien/Atkins Associates, PA April 1999 - April 2013
Skills
Construction Drawings, Submittals, Revit, LEED, AutoCAD, Construction..., Autodesk BIM 360..., Change Orders, Close Attention to..., Architectural Details, Architectural Inspection, Interscope, Primavera Professional..., Space Planning, Architectural Design, Construction Management, SketchUp, Microsoft Office, Renovation, Proposal Writing, Furniture, LEED AP, BIM, CAD, Downsizing, Space planning, Sustainable Design, Residential Homes, Green Building, Design Research
Education
East Carolina University
Bachelor of Science (B.S.), Political Science and Government
Durham Technical Community College
Diploma, Architectural Drafting and Architectural CAD/CADD
BE&K Building Group October 2014 - September 2015
NNE Pharmaplan September 2013 - July 2014
KBR Engineering , Inc. February 2011 - July 2013
Skills
Document Management, Documentum, Microsoft Access, Visio, SharePoint, Outlook, Adobe Acrobat, Administrative..., Administrative..., Project Management, Construction Management, Customer Service, Construction, Software Documentation, AutoCAD, Project Planning
Education
Miller-Motte College 2006 — 2006
Diploma, Esthetics
Wake Technical Community College 1999 — 2003
Associate's degree, General Studies
NNE Pharmaplan February 2014 - Present
Merck April 2012 - February 2014
Merck March 2009 - April 2012
Merck July 2007 - March 2009
GSK 2005 - 2006
Johnson & Johnson 2004 - 2005
Skills
Consulting Engineering, Automation, Computer System..., 21 CFR Part 11, Instrumentation, GMP, Process Automation, FDA, Process Engineering, Change Control, Engineering, Control Systems Design, Process Simulation, Allen Bradley, Emerson DeltaV, Project Management, Electrical Engineering, Pharmaceutical Industry, DCS, Technology Transfer, Biotechnology, SCADA, PLC, Commissioning, Process Optimization, Cross-functional Team..., SDLC, Testing, Resource Management, Technology Solution..., S88, Start-ups, Equipment Qualification
Education
La Salle University - School of Business Administration 2010 — 2012
MBA, Management Information Systems
Drexel University 2002 — 2007
BS, Electrical Engineering
IBM/Kenexa May 2014 - August 2015
Accountemps/OfficeTeam April 2013 - May 2014
Spectraforce Technologies Inc. June 2012 - December 2012
DSU Incorprated January 2012 - June 2012
NNE Pharmaplan November 2010 - May 2011
Skills
Toastmasters, Technical Recruiting, Recruiting, Applicant Tracking..., Sourcing, Internet Recruiting, Talent Acquisition, Employee Relations, Human Resources, Benefits Negotiation, Onboarding, Contract Recruitment, Screening, College Recruiting, Employee Engagement, Screening Resumes, Talent Management, Performance Management, Executive Search, Organizational..., HRIS, ADP Payroll
Education
Wake Technical Community College 2011 — 2011
Human Resources Management Certification
Barton College 2008 — 2010
Bachelor of Science, Secondary Education
Novo Nordisk July 2014 - Present
NNE Pharmaplan January 2014 - July 2014
NNE Pharmaplan March 2008 - January 2013
Johnston Community College May 2005 - May 2007
Skills
Visio, V&V, Microsoft Office, Management, Biotechnology, GMP, Pharmaceutical Industry, Validation, 21 CFR Part 11, FDA, Biopharmaceuticals, Change Control
Education
North Carolina State University 2001 — 2005
Bachelor of Arts (B.A.), English
VolPal January 2015 - Present
Michael Overton Consulting November 2013 - December 2014
NNE Pharmaplan January 2010 - October 2013
Drug Development Resources April 2007 - January 2010
Acambis 2003 - 2007
Wyeth 2000 - 2003
Biogen 1988 - 2000
Skills
Biotechnology, GMP, Validation, Technology Transfer, Lifesciences, FDA, Pharmaceutical Industry, Vaccines, Microbiology, Regulatory Affairs, Medical Devices, CAPA, Manufacturing, 21 CFR Part 11, Change Control, Biopharmaceuticals, V&V, GxP
Education
Central Michigan University
MS, Administration
Boston University
BA, Biology
NNE Pharmaplan May 2014 - Present
NNE Pharmaplan September 2013 - Present
NNE Pharmaplan January 2012 - September 2013
NNE Pharmaplan January 2011 - January 2012
NNE Pharmaplan October 2009 - March 2011
NNE Pharmaplan May 2004 - August 2009
Head Engineering July 2002 - April 2004
AstraZeneca Pharmaceuticals February 2001 - June 2002
Eka Chemicals August 1997 - February 2001
Skills
International Project..., Project Management, Pharmaceutical Industry, Management, Aseptic Processing, GMP, Conceptual Design, Business Strategy, Engineering Management, Engineering, Design Engineering, Process Improvement, Strategy, Biopharmaceuticals, Change Control, GAMP, V&V, Validation, FDA
Education
SIMI 2004 — 2005
Kungliga tekniska högskolan 1992 — 1997
Master of Science, Chemical Engineering
Hawkins Construction Company July 2015 - Present
Novozymes August 2011 - December 2014
NNE Pharmaplan August 2011 - September 2012
Fagen Inc. June 2008 - September 2008
Fagen Inc. March 2007 - September 2007
Skills
Construction, Project Management, AutoCAD, Project Engineering, Piping, Primavera P6, Construction Management, Contract Management, Engineering, Factory, Construction Safety, Project Control, Contractors, Inspection, Microsoft Office, Customer Service, Electricians, Commissioning, Project Estimation, Strategic Planning, Concrete, Training, Project Planning, Leadership, Management, Microsoft Word, Design, Remediation, Document Management, 3D Design, Schematic design, Materials, Steel Structures, HVAC, Instrumentation, Microsoft Project, Time Management, Budgets, CPRS, RFI
Education
University of Nebraska at Omaha 2008 — 2011
Bachelor’s Degree, Bachelor of Science (B.S.), Construction Management
Iowa Western Community College 2004 — 2006
Associate’s Degree, Architectural Engineering Technologies/Technicians
Time Warner Cable July 2013 - Present
Aptiv Solutions & Western Carolina Univeristy 2012 - 2013
NNE Pharmaplan 2006 - 2012
Vanguard America Company 2004 - 2006
Skills
Employee Relations, Talent Management, HRIS, Human Resources, Employment Law, Performance Management, Personnel Management, Benefits Administration, Onboarding, Career Development, Organizational..., Employee Benefits, New Hire Orientations, Recruiting, Employee Engagement, HR Policies, HR Consulting, Employee Handbooks, Employee Training, Technical Recruiting, Strategy, Staff Retention, Strategic Human..., Management, Compensation & Benefit, Change Management, Human Resource..., Human Resource Planning, Global Human Resources..., Training, Workforce Planning, Talent Acquisition, Succession Planning
Education
North Carolina Wesleyan College
Bachelor's Degree
Western Carolina University
Master's Degree
NNE Pharmaplan April 2012 - Present
Progress Energy May 2011 - April 2012
NNE Pharmaplan May 2009 - May 2011
Novartis Vaccines and Diagnostics February 2010 - July 2010
NCSRT December 2006 - May 2009
Novo Nordisk A/S September 2005 - August 2006
US Navy August 1999 - August 2005
Skills
Engineering, GMP, PLC, Automation, Validation, Process Engineering, Control Systems Design, Instrumentation, Calibration, Commissioning, Control Logic, Preventive Maintenance, CAPA, Manufacturing, HMIs, Variable Frequency..., Allen Bradley, Root Cause Analysis, Troubleshooting, PLC Programming, Power Generation, SCADA, Process Automation, Process Control, GAMP, Nuclear, Maintenance Management, Computer System..., Power Plants, Change Control, DCS, Electricians, Engineering Management, Factory, Plant Maintenance, Power Distribution, Process Optimization, Process Simulation, Project Engineering, Robotics, Steam, Electrical Engineering, Emerson DeltaV, Electrical Controls, Electrical..., Generators, Electrical Safety, Maintenance, Maintenance & Repair, Allen-Bradley
Education
Wake Technical Community College 2013 — 2016
Associate of Science (A.S.), Computer Programming
Excelsior College 2011 — 2013
Bachelors of Science, Nuclear Engineering Technology
Wake Technical Community College 2007 — 2010
Nuclear Power Training Unit (MARF) 2000 — 2001
Nuclear power operations
Naval Nuclear Power School 2000 — 2000
Nuclear Power
Navy Nuclear Electrician's Mate 'A' School 1999 — 2000
Electrical
Keystone Highschool
NNE Pharmaplan April 2014 - Present
Novo Nordisk February 2011 - April 2014
NNE Pharmaplan June 2010 - April 2014
Covidien September 1999 - March 2010
Avid Solutions 2010 - 2010
International Paper 1999 - 2000
UCB Chemicals November 1995 - January 1999
Robert E Mason Company June 1993 - November 1995
Skills
Six Sigma, Lean Manufacturing, GAMP, Change Management, Process Improvement, Strategic Planning, PLC, DCS, Manufacturing, Change Control, Validation, Cost Control, Allen Bradley, 21 CFR Part 11, Operations Management, GMP, Project Management, Computer System..., Pharmaceutical Industry, GxP, Instrumentation, Process Control, Project Engineering, Automation, Process Engineering, ISO, FDA, Engineering Management, Factory, Quality System, Control Systems Design, CAPA, Process Simulation, V&V
Education
University of South Carolina - The Moore School of Business 1997 — 1999
MBA
Clemson University 1989 — 1993
Bachelor of Science, Electrical Engineering
PBM, INC. Valve Solutions February 2015 - Present
CPFS July 2013 - 2015
NNE Pharmaplan December 2010 - June 2013
Bosch Packaging Technology January 2008 - January 2011
Skills
Validation, Medical Devices, Pharmaceutical Industry, Biotechnology, Lifesciences, FDA, Cross-functional Team..., Manufacturing
Education
Rutgers Graduate Business School 1997 — 2000
MBA, Mktg / Int'l Bus
Rutgers University 1986 — 1989
BS, Econ/Finance
NNE Pharmaplan March 2014 - Present
ABB June 2012 - February 2014
Progress Energy January 2009 - August 2011
Skills
Engineering, Control Logic, ABB 800xA, Batch Programming, HMI Programming, Performance Testing, FactoryTalk View, RSLogix, PI Data Historian, Batch Records, OEE, Automation, SCADA, PLC, PLC Programming, OPC, ControlLogix, Microsoft Office, People Skills, Leadership
Education
North Carolina State University
Bachelor of Science (B.S.), Mechanical Engineering
PRA Health Sciences September 2014 - Present
UCB Biosciences, Inc (Contract Position) August 2013 - September 2014
Bosch Packaging Services, Inc (Contract Position) June 2013 - September 2013
NNE Pharmaplan March 2013 - May 2013
INC Research September 2012 - February 2013
UCB Biosciences, Inc April 2011 - June 2012
UCB Biosciences, Inc. April 2007 - April 2011
UCB Biosciences, Inc November 2005 - April 2007
UCB Biosciences, Inc April 2005 - November 2005
Skills
Accounts Payable, Financial Reporting, Financial Analysis, Procurement, Reconciliation, SAP, Accounting, Spreadsheets, Customer Relations, Budgeting, Forecasting, Purchasing, General Ledger, Microsoft Excel, Account Reconciliation, Human Resources, Internal Controls, SAP R/3, System Administration, Account Management, Invoicing, Project Management, Leadership, Finance, Clinical Trials, Team Management, Pharmaceutical Industry, Regulatory Requirements, Outsourcing, CRO, Budgets
Education
Boston University 2010 — 2012
Master of Science, Project Management
East Carolina University 2007 — 2009
Bachelor of Science, Communications
NNE Pharmaplan May 2014 - Present
Dansk Kommunikationsforening May 2011 - Present
NNE Pharmaplan October 2013 - May 2014
StepUp Ministry June 2013 - March 2014
Visma March 2011 - June 2013
De Unge Kommunikatører (UngKom) February 2010 - May 2011
Dethlefsen Communication January 2011 - March 2011
Ungdommens Røde Kors October 2010 - January 2011
IBM January 2010 - September 2010
IBM September 2008 - December 2009
Skills
Google Analytics, Microsoft Office, HTML, Lotus Notes, Public Affairs, Google Adwords, Wordpress, CSS, SEO, CMS, Social Media Marketing, Blogging, CRM, Online Marketing, Web Design, Entrepreneurship, Web Analytics, Email Marketing, Social Media, Internal Communications, Digital Media, WordPress
Education
NC State University 2013 — 2013
Summer School, English as a Second Language
Copenhagen Business School 2007 — 2010
Master, MSocSc in Political Communication & Management
IT-Universitetet i København 2008 — 2009
Course:, Media and communication
Roskilde University 2004 — 2007
Bachelor, Bachelor in Business Administration
Herlev Gymnasium 2000 — 2003
Student, Language student
North Carolina State University January 2013 - Present
NNE Pharmaplan January 2012 - January 2013
North Carolina State University August 2008 - September 2011
North Carolina State University April 2007 - August 2007
Duke Energy Corporation June 2005 - July 2006
Skills
Erosion Control, Watershed Management, Stormwater Management, Groundwater, Sampling, Analysis, Water, Hazardous Waste..., Soil Science
Education
North Carolina State University 2008 — 2011
M.S. Biological Engineering
North Carolina State University 2004 — 2008
B.S. Biological Engineering, Environmental Engineering Concentration
NNE Pharmaplan April 1996 - Present
NNE Pharmaplan January 2010 - January 2011
NNE Pharmaplan January 2007 - January 2010
NNDT 2007 - 2008
PT. Sorini November 1994 - April 1996
Pedersen Engineering Ltd. November 1993 - November 1994
Kruger 1993 - 1993
Education
Stanford University Graduate School of Business 2009 — 2009
Finance & Accounting for Nonfinancial Executives
PMI 2007 — 2007
PMP - Project Management Professional
Pathfinder 2005 — 2005
The Pathfinder Programme
Danmarks Tekniske Universitet 1989 — 1993
B.Sc., Mechanical Engineering
ConvaTec May 2014 - Present
Kajo Validation February 2010 - Present
IPS October 2013 - May 2014
Zimmer February 2011 - September 2013
MSH Validation / NNE Pharmaplan / Hospira June 2010 - December 2010
AVS November 2007 - March 2010
GlaxoSmithKline Biologicals 2007 - 2009
North American Medical August 2006 - May 2007
NNE Pharmaplan May 2005 - February 2006
Hospira March 2003 - May 2005
Skills
Validation, Regulatory and..., Mechanical Engineering, Manufacturing, Cleaning Validation, Quality Assurance, Project Planning, Six Sigma, Technology Transfer, Quality System, CAPA
Education
North Carolina State University 1998 — 2002
BS, Mechanical Engineering
NNE Pharmaplan July 2014 - Present
Biotechnology Research Lab, University of California at Irvine December 2012 - Present
Maxim Integrated June 2012 - August 2012
Cornell University Sustainable Design (CUSD) Project Team August 2010 - May 2012
Maxim Integrated June 2011 - August 2011
Schlumberger May 2011 - May 2011
Asha for Education, Cornell University September 2008 - May 2011
NanoTech Institute, University of Texas at Dallas May 2009 - August 2009
Skills
Matlab, Aspen Plus, Mathematica, Chemical Engineering, NI LabVIEW, Java, Microsoft Office, PCR, Yeast, International Exposure, R&D, Semiconductors, Simulations, Labview, Mathematical Modeling, Biomedical Engineering
Education
University of California, Irvine 2012 — 2014
Master of Science (MS), Chemical Engineering
Cornell University 2008 — 2012
Bachelor of Science (BS), Chemical Engineering
Plano West Senior High School 2006 — 2008
Singapore American School 1996 — 2006
NNE Pharmaplan May 2011 - Present
Genzyme 2004 - February 2011
GE Plastics September 1987 - June 2002
Ciba-Geigy 1983 - 1987
Skills
DeltaV Batch and..., Process Control, Start-ups, Process Engineering, Biotechnology, DCS, Process Automation, Manufacturing, GMP, Batch Processing, Emerson DeltaV, Profibus, Quality System, Automation
Education
Auburn University 1979 — 1983
Masters of Engineering, Chemical Engineering
Auburn University 1976 — 1978
Bachelors, Business Administration - Marketing
MSH Validation July 2006 - Present
The Janssen Pharmaceutical Companies of Johnson & Johnson 2015 - 2015
McNeil Consumer Healthcare January 2011 - October 2014
Hospira March 2010 - December 2010
Novartis May 2009 - March 2010
Sanofi Pasteur September 2007 - April 2009
bioMerieux July 2007 - September 2007
Cardinal Health July 2006 - May 2007
NNE Pharmaplan September 2004 - July 2006
Novo Nordisk Pharmaceutical Industries, Inc. December 2001 - July 2003
Skills
Validation, Project Management, Testing, Project Planning, 21 CFR Part 11, GMP, Computer System..., Change Control, V&V, FDA, Cross-functional Team..., Quality Management, Regulatory Requirements, GxP, Manufacturing, GAMP, R&D, Quality Control, Process Simulation, GLP, ISO, Quality System, Quality Assurance, Software Documentation, Clinical Development, Management, Regulatory Affairs, Commissioning, Sop, Lean Manufacturing, CAPA, Biopharmaceuticals, Quality Auditing, Lifesciences, Biotechnology, Vaccines, Technology Transfer, Pharmaceutical Industry, Engineering, Clinical Trials, LIMS, Medical Devices, Calibration, GCP, CRO, Cleaning Validation, Six Sigma, ISO 13485, Risk Assessment, Aseptic Processing
Education
Campbell University 1997 — 2001
BA, Computer Information Systems
Bristol-Myers Squibb July 2012 - Present
NNE-Pharmaplan August 2010 - July 2012
Pfizer April 2003 - August 2010
Pharmacia January 2000 - April 2003
VAI Automation (now CQS Innovations) January 1995 - April 2000
VAI Automation January 1990 - January 2000
Bethlehem Steel Corp July 1984 - January 1990
Skills
Validation, GMP, Manufacturing, 21 CFR Part 11, Software Documentation, Pharmaceutical Industry, Six Sigma, FDA, Change Management, Change Control, Computer System..., Automation, Leadership, Engineering, Project Management, GAMP, Process Automation, Quality System, Team Building, Cross-functional Team..., Process Improvement, PLC, Performance Management, Instrumentation, Quality Assurance, MES, CAPA, V&V, Batch Processing, Technology Transfer, Product Development, Sop, Testing, Biopharmaceuticals, Management, Continuous Improvement, Team Leadership, Training, Capital Budgeting, Chemical Processing, Fermentation, Allen Bradley, Pharmaceutics, Process Optimization, Budgets, Business Development, Biotechnology, Aseptic Processing, Process Simulation
Education
Villanova University 2011 — 2011
Master's Certification, Project Management
Michigan Technological University 1983 — 1984
BS, Engineering Administration
Michigan Technological University 1978 — 1983
BS, Mechanical Engineering
NNE Pharmaplan September 2014 - Present
Novo Nordisk A/S August 2012 - August 2014
Johnson & Johnson August 2011 - August 2012
Eneractive LLC March 2010 - August 2011
Centocor June 2009 - January 2010
McNeil Consumer & Specialty Pharmaceuticals September 2007 - April 2008
United Technologies - Pratt and Whitney September 2006 - April 2007
McNeil Consumer & Specialty Pharmaceuticals September 2005 - April 2006
Skills
Process Engineering
Education
Drexel University 2004 — 2009
B.S., Mechanical Engineering
NNE Pharmaplan December 2013 - Present
NNE Pharmaplan June 2012 - December 2013
The Body Shop January 2010 - June 2012
Dish Network April 2007 - October 2009
Case Design/Remodeling, Inc. September 2004 - June 2006
Mercer Human Resource Consulting 2002 - 2004
Skills
Employee Relations, Employee Benefits, Employment Law, Employee Handbooks, Employee Training, Workers Compensation, Compensation & Benefit, Recruiting, Performance Management, EEOC, Paralegals, Conflict Resolution, Drug Testing, Talent Management, Generalist Duties, Legal Documents, Unemployment Claims, Organizational..., Leadership Development, Internal Investigations, Employment..., Safety, Talent Acquisition, HRIS Database Management, Enterprise eTime, Peer Mediation, Drafting Policies, Onboarding, Succession Planning, Human Resources, Benefits Administration, HR Policies, Personnel Management, Training, FMLA, Policy, Performance Appraisal, New Hire Orientations, Coaching, HRIS, Applicant Tracking..., Interviews, Hiring, Employee Engagement, Job Descriptions, Legal Compliance, Management Development, ADP Payroll, Employee Recognition, EEO
Education
Duke University 2012 — 2012
Paralegal Certification, Paralegal Certification
State University of New York College at Brockport 1999 — 2001
BS, Communications
NNE Pharmaplan February 2010 - Present
Camstar Systems, Inc. May 2007 - February 2010
Flexware Innovation February 2002 - May 2007
Verid Technology February 2001 - February 2002
Technical University of Denmark February 1999 - February 2001
Military & Security Organization January 1988 - January 1994
Skills
Manufacturing Planning, Manufacturing Excellence, Operational Excellence, Manufacturing Systems, Software Design, MES, Quality Systems, Product Strategy, Production Management, Product Management, Market Analysis, Product Development, Strategy Development, Strategic Consulting, Software Consulting, Program Management, Management Consulting, Technical Leadership, Strategic Leadership, Product Marketing, Software Development, Business Analysis, Strategic Planning, Team Building, Business Intelligence, Agile Project Management, Software Modeling, Engineering, Cross-functional Team..., Software Project..., Project Planning, Business Strategy, Change Management, Process Improvement, Medical Devices, Continuous Improvement, Integration, Requirements Analysis, Mentoring, Enterprise Software, IT Strategy, Lean Manufacturing, Analysis, Agile Methodologies, Strategy, Project Management, Quality System, Marketing Strategy, Manufacturing, 21 CFR Part 11
Education
Danmarks Tekniske Universitet 1996 — 1999
Ph.D., Industrial Engineering, Software Engineering
Danmarks Tekniske Universitet 1990 — 1995
M.Sc., Manufacturing Engineering, Industrial Engineering
International School of Kenya 1979 — 1984
High School Diploma, N/A
IPS-Integrated Project Services, Inc. October 2014 - Present
NNE Pharmaplan November 2010 - October 2014
DanChem Technologies, Inc. July 2008 - October 2010
Corning Cable Systems April 2007 - May 2008
Corning Cable Systems August 2004 - April 2007
Cliffs Natural Resources May 2003 - July 2003
US Air Force November 1994 - July 2000
Skills
Cross-functional Team..., Six Sigma, Process Engineering, Lean Manufacturing, Project Management, Minitab, Product Development, Process Improvement, Manufacturing, Fiber Optics, SuperPro Designer, AutoCAD
Education
North Carolina State University 2001 — 2004
BS
Heron Therapeutics, Inc. February 2015 - Present
Raptor Pharmaceuticals April 2014 - October 2014
BioPharma Consulting LLC August 2013 - April 2014
ADVENT Engineering Services, Inc. February 2012 - August 2013
NNE Pharmaplan US January 2010 - December 2011
NNE Pharmaplan July 2008 - December 2009
Genentech, Inc October 2007 - April 2008
Genentech June 2004 - January 2008
Skills
Cross-functional Team..., Process Engineering, Project Management, Biotechnology, Consulting, V&V, Validation, FDA, GMP, cGMP manufacturing, Biopharmaceuticals, Automation, Strategy, Engineering, Quality Assurance, Technology Transfer, Manufacturing, Pharmaceutical Industry, CAPA, Medical Devices
Education
Saint Mary's College of California 2005 — 2007
MBA, Business
University of Massachusetts, Amherst 1981 — 1985
B.S. Mechanical Engineering
NNE Pharmaplan October 2014 - Present
Novartis Vaccines and Diagnostics September 2012 - October 2014
Novartis Vaccines and Diagnostics April 2011 - September 2012
Covidien December 2009 - April 2011
Covidien April 2008 - December 2009
GlaxoSmithKline September 2007 - April 2008
GlaxoSmithKline May 2007 - September 2007
MeadWestvaco October 2006 - May 2007
SONOCO May 2003 - May 2006
Skills
Root Cause Analysis, Lean Manufacturing, Process Improvement, cGMP, Product Development, Troubleshooting, Packaging, Continuous Improvement, Six Sigma, 5S, Manufacturing, Process Engineering, Cross-functional Team..., FMEA, Change Management, Operations Management, Team Leadership, GMP, Process Development, Validation, Sop, Analysis, Quality Control, CAPA, Engineering, Quality System, Project Planning, Aseptic Processing, Process Simulation, FDA, Quality Auditing, Operational Excellence, Leadership, ISO, Project Management, Kaizen, Technology Transfer, Management, Quality Management, Quality Assurance, Software Documentation, Strategy, Training, SOP
Education
North Carolina State University - College of Management 2006 — 2008
Masters in Business Administration (MBA), BioPharma Management and Finance
North Carolina State University 1998 — 2003
BS Paper Engineering, Paper/ Chemical Engineering
North Carolina State University 1998 — 2003
BA Chemistry, Chemistry
Raptor Pharmaceuticals January 2015 - Present
Grifols October 2014 - December 2014
Dynavax Technologies June 2012 - September 2014
Medicines360 February 2011 - February 2013
Onyx Pharmaceuticals March 2011 - September 2012
MAP Pharmaceuticals September 2011 - July 2012
NNE Pharmaplan June 2010 - October 2011
Novartis Vaccines and Diagnostics April 2010 - June 2010
Threshold Pharmaceuticals June 2005 - June 2010
Bayer HealthCare April 2009 - January 2010
Skills
GMP, Validation, Quality Assurance, Aseptic Processing, Manufacturing, Start-ups, Regulations, FDA, CAPA, V&V, Change Control, Sop, Pharmaceutical Industry, Quality System, Biotechnology, IND, Quality Auditing, GxP, R&D, Biopharmaceuticals, 21 CFR Part 11, GLP, Regulatory Affairs, Computer System..., Pharmaceutics, ISO 13485, Regulatory Submissions, GAMP, Cleaning Validation, LIMS, Regulatory Requirements, Medical Devices, SOP
Education
Drexel University 1987 — 1992
BS, Chemistry
Delaware Valley High School 1983 — 1987
Independent consultant for Life Science & Cleanroom Industries September 2014 - June 2015
NNE Pharmaplan January 2014 - September 2014
Independent Consultant for Project Management & Process Architecture June 2013 - December 2013
Jacobs Engineering September 2010 - June 2013
Jacobs Engineering 2006 - January 2010
Fluor 2002 - 2005
ISPE 1993 - 2002
Sear Brown Sikorsky (Stantec, Inc) 1999 - 2001
BE&K Building Group 1997 - 1999
O'Neal, Inc. 1995 - 1997
Skills
Project Management, Construction, Feasibility Studies, Submittals, Engineering, Comprehensive Planning, Construction Management, Manufacturing, Construction Drawings, GMP, Project Engineering, AutoCAD, Architectural Design, Architecture, Design Management, Architectures, Building Design, Facilities Management, CAD, Construction..., Design Research, Revit, Facility Master Planning, API Suite Design, OSD Design, Warehousing, Pharmaceutical Industry, Facility Programming, cGMP Facility Design, Laboratory Planning, Construction Documents, Construction Technical..., Forensic Evaluation, International Travel..., R&D & QC Lab Design, Vivarium Design, Pilot Plant Design, Small & Medium Scale..., BSL-2 & 3 Experience, Biopharm Primary..., Wafer Fabrication..., Thin Film Facilities..., Warehouse Design, Government Facilities..., FEMA Project Officer..., Corporate Office Design, 2D & 3D hand sketching, New Business Development, Display Booth Design, Marketing Brochure...
Education
Columbia University - Graduate School of Architecture, Planning and Preservation 1970 — 1972
MSUP, Urban Design & Urban Planning, Top 3 of 22
Naval Aviation Schools Command, Pensacola, Fla 1968 — 1969
USNR Officer, Flight Training - Ground School
Pratt Institute 1963 — 1968
Bachelor Of Architecture, Architecture, Top 5 of 72
ETGXP Compliance Services, LLC November 2014 - Present
NNE Pharmaplan August 2011 - October 2014
Eisai December 2008 - April 2011
Underwriters Laboratories June 1989 - August 2002
Education
North Carolina Agricultural and Technical State University 1987 — 1989
BS, Electrical Engineering
North Carolina State University 1983 — 1986
Electrical Engineering
NNE Pharmaplan July 2015 - Present
Ballinger November 2010 - June 2015
Kutnicki Bernstein Architects February 2007 - November 2010
Rexrode Chirigos Architects October 2007 - April 2008
The New School, Parsons School of Design January 2007 - October 2007
Maryland Archaeological Conservation Lab September 2003 - June 2004
Skills
Architecture, Submittals, Sustainable Design, Construction Management, Sustainability, Construction, Interior Design, Architectural Design, Project Management, Revit, Construction..., Healthcare, Adobe Creative Suite, Sustainable Architecture, Feasibility Studies, Adaptive Reuse, Space planning, Residential Design, Construction Drawings, Green Building, Renovation, InDesign, Design Research, Ecotect, LEED AP, SketchUp, Mixed-use, Historic Preservation, Interior Architecture, AutoCAD, Architectural Drawings, Laser Cutting, Photoshop, Illustrator, Adobe Acrobat, Budgets, LEED, Rendering, Comprehensive Planning, AutoCAD Architecture, Space Planning
Education
Parsons School of Design 2005 — 2008
Master of Architecture (MArch)
Williams College 1999 — 2003
BA
International Honors Program 2001 — 2002
NNE Pharmaplan March 2015 - Present
Amgen June 2014 - Present
SRG Consulting January 2008 - Present
Emcure Pharmaceuticals Limited May 2014 - May 2014
DePuy Synthes, Division of J&J November 2013 - December 2013
Teva Pharmaceuticals January 2013 - November 2013
Quality and Compliance Partners January 2012 - April 2012
Promega March 2011 - November 2011
Genentech March 2011 - May 2011
Nopras Technologies Inc. March 2010 - May 2010
Skills
Validation, Quality Systems, FDA, GMP, Medical Devices, Biotechnology, Process Validation, Microbiology, Quality Assurance, cGMP, Pharmaceuticals, Compliance, Process Improvement, Change Control, 21 CFR Part 11, Risk Management, SOP, Quality Management, Auditing, Documentation, CAPA, Problem Solving, GxP, Life Sciences, Internal Audit, Cross-functional Team..., Document Management, Change Management, Customer Relations, GLP, Strategic Planning, Coaching, Computer System..., ISO 13485, Quality Auditing, LIMS, GCP, Risk Assessment, Compliance Audits, Compliance Management, Quality System, Pharmaceutical Industry, V&V, Sop, GAMP, Regulatory Requirements, Technology Transfer, Biopharmaceuticals, Quality Control, Aseptic Processing
Education
Montclair State University 1986 — 1991
MA, Biology/Microbiology
Bloomfield College 1977 — 1981
BS, Biology/ Business Law
Juno Therapeutics April 2014 - Present
CMC ICOS Biologics May 2010 - April 2014
NNE Pharmaplan August 2008 - May 2010
Bayer Pharmaceuticals 2007 - 2008
Bayer HealthCare 2006 - 2007
Berlex Laboratories 2002 - 2007
Berlex Incorporated 2002 - 2006
Amgen 2001 - 2002
immunex 1992 - 2002
Skills
Validation, Biotechnology, Technology Transfer, Project Management, Project Planning, GMP, Automation, Pharmaceutical Industry, FDA, Biopharmaceuticals, V&V, Change Control, CAPA
Education
Marquette University 1987 — 1992
BS, Mechanical Engineering
Process Design Solutions August 2009 - Present
NNE Pharmaplan October 2008 - August 2009
Wyeth Biotech November 2006 - October 2008
Wyeth Biotech June 2002 - November 2006
Universal Pharma Technologies (UPT) March 2001 - June 2001
Genzyme June 2000 - December 2000
Salem Hospital May 1998 - May 2000
New England Biolabs May 1997 - September 1997
Skills
Validation, Biotechnology, HPLC, GAMP, Computer System..., Automation, Commissioning, Testing, Troubleshooting, GMP, 21 CFR Part 11, CAPA, FDA, V&V, DCS, Manufacturing Operations, Purification, Process Simulation, Biopharmaceuticals, Change Control, Aseptic Processing, Sop, GxP, Laboratory, Cleaning Validation, Technology Transfer, Filtration, LIMS, Fermentation, SOP
Education
Northeastern University 1997 — 2002
BS, Chemical Engineering
Salem State College 2003 — 2004
Pre-Medicine/Pre-Medical Studies
NNE Pharmaplan July 2010 - Present
Baxter Healthcare April 2007 - October 2009
Hospira August 2006 - March 2007
Skills
Minitab, GLP, Risk Assessment, GDP, FDA, Design of Experiments, Medical Devices, Validation, GMP, CAPA, V&V, Biotechnology, MES, cGMP practices, PAS-X, Visio, Pharmaceutical Industry, R&D, ISO, Polymers, Testing, ISO 13485, Manufacturing, Change Control
Education
Northwestern University
Master of Engineering Management
University of Illinois at Chicago 2002 — 2006
B.S., Bioengineering
Northeast Controls October 2011 - Present
NNE Pharmaplan May 2011 - October 2011
SI Group August 2005 - May 2011
Northeast Controls July 2000 - June 2005
IBM 1998 - 2000
Education
University at Albany 2003 — 2008
MBA, Masters Business Administration - Information Technology
Rensselaer Polytechnic Institute 1995 — 1998
BS, Chemical Engineering
Hudson Valley Community College 1995 — 1996
University at Albany, SUNY 1989 — 1994
Bachelor of Arts, English
Process Automation Solutions - An ATS Company February 2015 - Present
NNE Pharmaplan January 2014 - January 2015
NNE Pharmaplan December 2011 - December 2013
NNE Pharmaplan September 2008 - December 2011
Amgen January 2007 - August 2008
GlaxoSmithKline 2002 - 2006
Novozymes NA June 1993 - June 2001
Skills
Management, Validation, GMP, Change Control, FDA, V&V, GAMP, Technology Transfer, Quality System, Process Engineering, CAPA, Lifesciences, MES, Project Management, 21 CFR Part 11, Sop, Process Automation, Change Management, Automation, GxP, SCADA, Pharmaceutical Industry, Process Control, Computer System..., Aseptic Processing, Biotechnology, Process Optimization, Cross-functional Team..., Life Sciences, Manufacturing, Team Leadership, Biopharmaceuticals, Business Development
Education
Duke University - The Fuqua School of Business 2000 — 2001
MBA, Business Administration
Louisiana Tech University 1981 — 1985
BS, Chemical Engineering
NNE Pharmaplan May 2014 - Present
Baxter Healthcare August 2012 - May 2014
Genzyme October 2009 - August 2012
Genzyme 2007 - 2009
Amgen 2003 - 2007
Skills
Change Control, GMP, Validation, Biotechnology, CAPA, V&V, LIMS, 21 CFR Part 11, FDA, Pharmaceutical Industry, Biopharmaceuticals, Sop, Aseptic Processing, Computer System..., Aseptic Technique, Quality System, Quality Control, Manufacturing, GxP, GLP, Technology Transfer, SOP
Education
Penn State University 1999 — 2003
Chemical engineering
Mt. Lebanon High School
Gilead Sciences August 2014 - Present
NNE Pharmaplan September 2008 - August 2014
Genentech January 2005 - September 2008
Alien Technology January 2001 - December 2004
Tetra Tech MPS August 1998 - December 2000
Skills
PLC, PanelView, VMware ESX, iFix, FactoryTalk View, Control Logic, Automation, SCADA, GAMP, Process Control, Process Automation, Engineering, Calibration, MES, Control Systems Design, Validation, Wonderware, GMP, Manufacturing
Education
Santa Clara University 2006 — 2009
MS, Engineering Management
Western Michigan University 1995 — 1998
BSc., Electrical Engineering
GlaxoSmithKline June 2011 - Present
NNE Pharmaplan October 2010 - January 2011
Wake County Public Schools December 2009 - October 2010
Covidien 2005 - September 2009
Mallinckrodt 1989 - 2005
Education
Virginia Polytechnic Institute and State University
BS, Chemical Engineering
North Carolina State University
Certificate, Computer Programming
Independent Contractor September 2013 - Present
ADVENT Engineering Services, Inc. 2013 - September 2013
NNE Pharmaplan December 2010 - December 2012
Genentech April 1979 - July 2009
Skills
Biopharmaceuticals, Computer System..., Change Control, Validation, Biotechnology
Education
San Jose State University 1974 — 1977
BS, Biology, Psychology
NNE Pharmaplan November 2009 - Present
AstraZeneca March 2006 - March 2009
Abbott Bioresearch Center April 2002 - April 2006
Millipore 2000 - 2001
Genzyme Corporation 1996 - 1998
Process Facilities, Inc. 1996 - 1998
Remediation Technologies, Inc. March 1991 - March 1996
Metcalf and Eddy, Inc. 1989 - 1991
Arthur D. Little 1985 - 1989
Skills
Biotechnology, Commissioning, Technology Transfer, Process Engineering, Process Design, Validation, Project Planning, GMP, Process Simulation, Sop, R&D, Process Optimization, Petrochemical, P&ID, FDA, Aseptic Processing, Filtration, Quality System, Pharmaceutical Industry, Change Control, Product Development, FMEA
Education
Northeastern University 1987 — 1989
MS Chemical Engineering
University of Massachusetts, Amherst 1980 — 1983
BS, Chemical Engineering
McGill University 1974 — 1978
BS, Biology
NNE Pharmaplan April 2014 - Present
Mid-South Engineering Co. August 2012 - February 2014
Hipp Engineering November 2007 - August 2012
Cundiff Engineering & Consulting May 2000 - November 2004
US Navy 1989 - 1996
Skills
Project Management, Electrical Systems..., Lighting Design, Fire Alarm System Design, Code Research, AutoCAD, Microstation, Visual Basic, AGI32, Microsoft Office 2007, Electrical Systems..., Electrical Systems..., Electrical Maintenance..., Managing Database..., Technical Writing, PTW, Easy Power, Design Specifications, Electrical Engineering, Electricians, Military Experience, Maintenance Management, Nuclear, Navy, Project Engineering, CAD, Troubleshooting, AGI 32, Electrical Design, MEP, Fire Alarm, Systems, Codes, Power Distribution, Commissioning, Engineering
Education
Portland Community College 2005 — 2007
Associate of Science (AS), Physics & Chemistry
Sequoyah High 1984 — 1989
High School, General Education/Science
Naval Nuclear Power School
Naval Nuclear Power School
Biotest Laboratories (A subsidiary of STERIS Corp.) February 2014 - Present
STERIS Corporation August 2008 - Present
NNE Pharmaplan June 2005 - August 2008
NNE 2005 - August 2008
NNE Pharmaplan US 2005 - 2008
Wyeth 2003 - 2005
Wyeth Biotech 2003 - 2005
Pharmacia October 2001 - July 2003
Boehringer Ingelheim Vetmedica August 1999 - September 2001
Black & Veatch January 1997 - July 1999
Education
Baker University 1999 — 2001
MBA
Iowa State University 1993 — 1996
BS, Chemical Engineering
GSK September 2014 - Present
GSK April 2012 - September 2014
GSK April 2011 - April 2012
GSK November 2010 - April 2011
GSK July 2009 - November 2010
GSK May 2007 - July 2009
GSK August 2006 - May 2007
GSK June 2005 - August 2006
NNE Pharmaplan December 2004 - May 2005
Aerotek @ GlaxoSmithKline November 2002 - December 2004
Skills
Validation, GMP, Six Sigma, FDA, Cleaning Validation, Pharmaceutical Industry, CAPA, Cross-functional Team..., Quality System, Continuous Improvement, Change Control, Engineering, Value Stream Mapping
Education
Georgia Institute of Technology 1995 — 1998
BME, Mechanical Engineering
University of Cincinnati 2000 — 2002
MBA, Finance
NNE Pharmaplan March 2014 - Present
M+W Group May 2011 - March 2014
Parsons March 2005 - May 2011
Aker Kvaerner April 2001 - March 2005
Jacobs Engineering May 1996 - March 2001
Chiron Corporation March 1993 - April 1995
Skills
Process Architecture, Lifesciences, Building Design, Construction, Submittals, Revit, LEED, Architectural Design, BIM, Design Research, Construction Management, AutoCAD, Microstation, Comprehensive Planning, Feasibility Studies, CAD, Modeling, Space planning, Value Engineering, Sustainable Design
Education
Northeastern University 1983 — 1985
Master of Science, Civil Engineering, Construction Engineering
University of Miami 1978 — 1983
Bachelor of Architecture, Architecture
GSK April 2014 - Present
NNE Pharmaplan September 2010 - April 2014
SmartFlow Technologies September 2008 - August 2010
Talecris Biotherapeutics 2005 - 2008
Wyeth March 2004 - September 2005
Skills
V&V, Validation, GMP, Cleaning Validation, GxP, CAPA, 21 CFR Part 11, Technology Transfer, Aseptic Processing, GAMP, Process Simulation, Computer System..., Process Optimization, FDA, Change Control, Pharmaceutical Industry
Education
North Carolina State University 2001 — 2003
M.S., Chemical Engineering
Virginia Polytechnic Institute and State University 1996 — 2001
B.S., Chemical Engineering
NNE Pharmaplan October 2005 - Present
Education
RWTH Aachen University
Diploma, Chemical engineering
Raleigh Precision Products September 2014 - Present
NNE Pharmaplan February 2008 - August 2014
Cooper-Standard Automotive February 2005 - November 2007
Cooper-Standard Automotive August 2002 - February 2005
Ark-Les Corporation November 2001 - August 2002
Ark-Les Corporation August 1998 - November 2001
Fasco Controls Corporation July 1997 - August 1998
Federal Molding Company May 1995 - July 1997
Custom Molders, Inc 1993 - 1995
Skills
Six Sigma, DMAIC, Lean Manufacturing, Design of Experiments, Statistics, FMEA, Process Improvement, Quality System, Injection Molding, Kaizen, 5S, Minitab, Black Belt, Validation, Medical Devices, SMED, Value Stream Mapping, Process Capability, GMP, Process Optimization, Business Process..., Continuous Improvement, QFD, Gage R&R, Manufacturing, Process Engineering
Education
North Carolina State University 1987 — 1993
Bachelor of Science in Mechanical Engineering, Mechanical Engineering
CROSSMARK June 2014 - Present
Boston University January 2009 - November 2013
NNE Pharmaplan 2007 - 2008
Kuchler & Company May 1997 - June 2006
Skills
Administrative..., Leadership, Management, Microsoft Office, Program Management, Customer Service, Community Outreach, Microsoft Excel, Project Management, PowerPoint, Data Analysis, Analysis, Event Planning, Higher Education, Microsoft Word, Windows, Team Building, Project Planning, Program Development, Student Affairs, QuickBooks, Higher Education..., Public Speaking, Creative Writing, Editing, Volunteer Management, Student Development, Fundraising, Distance Learning, Curriculum Design, Admissions, International Education, University Teaching, Academic Administration, Leadership Development, Qualitative Research, Teaching, Academic Advising, Visio, Proofreading, Access, Nonprofits
Education
Boston University 2010 — 2016
Bachelor's degree
University of Phoenix 2008 — 2009
Chaminade University of Honolulu 1995 — 1996
RCM Technologies June 2015 - July 2015
RCM Technologies March 2013 - June 2015
Pharmaceutical Validation Solutions, Inc 2010 - March 2013
RCM Technologies March 2009 - December 2009
NNE Pharmaplan July 2007 - December 2008
Pharmaplan 1998 - 2007
Skills
Validation, Reactor, GMP, V&V, FDA, Computer System..., Quality System, GAMP, GxP, ISO, Medical Devices, Automation, Commissioning, Biotechnology, Process Simulation, Sop, Process Engineering
Education
Arizona State University
Master Engineering Technology, Mechanical
Fairleigh Dickinson University 1974 — 1976
BSME, Mechanical Eng
Biogen April 2015 - Present
Biogen Idec RTP, NC April 2014 - March 2015
Biogen Idec January 2012 - April 2014
NNE Pharmaplan January 2010 - January 2012
Thompson Construction Group August 2009 - January 2010
BE&K a KBR Company June 2004 - August 2009
IPS June 2001 - June 2004
Skills
Power Plants, HVAC, Facilities Management, GMP, Construction, Project Engineering, Project Planning, Ventilation, P&ID, Steam, Factory, V&V, Piping, Dust Collection, Commissioning, Budgets, Engineering, Validation, Process Engineering, GAMP, Project Management
Education
North Carolina State University 1996 — 2002
Master of Science, Mechanical Engineering
Biogen Idec June 2010 - Present
NNE Pharmaplan June 2004 - June 2010
CRB Consulting Engineers 2001 - 2004
Obrien Atkins 1999 - 2001
L.E.Wooten Company 1998 - 1999
O'Neal Engineering 1997 - 1998
Skills
DeltaV, SCADA, DCS, Process Control, Automation, cGMP, GAMP, Validation, Biotechnology, Process Automation, Process Simulation, Allen Bradley, Control Systems Design, Control Logic, Instrumentation, Change Control, MES, GxP, WebDAV, V&V, 21 CFR Part 11, Computer System..., CAPA, GMP, Commissioning, Calibration, TWS, PLC
Education
North Carolina State University 1999 — 2004
BS, Computer Science
Novozymes April 2013 - Present
Novozymes April 2009 - March 2013
NNE Pharmaplan May 1993 - April 2009
Wolfking May 1990 - May 1993
Krüger Veolia 1987 - 1990
Skills
GMP, Biotechnology, Validation, cGMP, Pharmaceuticals, Change Management, Life Sciences, Strategic Planning, Biopharmaceuticals, Management Consulting, Coaching, Engineering, Planning, Project Execution, Program Management, Strategy Development, Project Portfolio..., Pharmaceutical Industry, Project Management, Lifesciences, Business Strategy, Management, Quality Assurance, Start-ups, Strategy, Project Planning, Technology Transfer, 21 CFR Part 11, Leadership, Process Engineering, Process Simulation, Change Control, Analysis, Project Coordination, Managerial Finance
Education
Copenhagen Business School 1998 — 1999
HD 2. Graduate Diploma (part I and II), Organisation and environment management, Diploma
Københavns Teknikum 1982 — 1987
B.Sc.Eng.
Haslev Gymnasium 1979 — 1982
Student, Mat Fys
Kalvehave Skole 75 1969 — 1975
Folkeskolen
Novo Nordisk January 2014 - Present
NNE PHARMAPLAN November 2006 - Present
SYNGENTA BIOTECHNOLOGY INC August 2005 - November 2006
GOLDEN ISLES TRANSPORTATION May 2004 - August 2005
Progress Energy August 2002 - May 2004
Christy L July 1998 - July 2002
Bayer Corporation July 1998 - July 2002
BAYER CORPORATION July 1998 - July 2002
Pharmacia November 1992 - June 1998
Skills
GAAP, Cost Accounting, Account Reconciliation, Accruals, Journal Entries, Internal Controls, Financial Statements, Consolidation, Accounts Receivable, Internal Audit, Corporate Tax, Payroll, Financial Forecasting, Year-end Close, Analysis, Tax, Project Management, QuickBooks, Financial Audits, Invoicing, Finance, Revenue Recognition, Financial Accounting, Cash Flow, Bank Reconciliation
Education
North Carolina Wesleyan College 1989 — 1992
B.S, Business Administration
JOHNSTON COMMUNITY COLLEGE
A.A.S, Accounting
Merck October 2014 - Present
NNE Pharmaplan June 2012 - April 2014
NNE Pharmaplan June 2010 - September 2012
Trinity Biotech, Plc. July 2007 - June 2010
bioMerieux July 2005 - July 2007
bioMerieux April 2001 - June 2005
bioMerieux September 1999 - April 2001
LabCorp May 1998 - September 1999
Skills
GMP, V&V, Quality Control, Six Sigma, Biotechnology, Manufacturing, GxP, Design of Experiments, 5S, Kaizen, Technical Writing, Laboratory, Project Management, Pharmaceutics, Validation, Quality System, FDA, Leadership, CAPA, Change Control, Technology Transfer
Education
North Carolina State University 1993 — 1998
BS, Zoology
NNE Pharmaplan November 2013 - Present
HJ Russell & Company August 2012 - November 2013
Bath & Body Works November 2010 - February 2013
Fluor December 2011 - July 2012
Yonkers Industries, Inc. March 2011 - December 2011
Independent Contractor May 2010 - January 2011
Skanska USA Building Inc. July 2008 - January 2010
Bovis Lend Lease May 2004 - July 2008
Skills
AutoCAD, Microsoft Office, On-Screen Takeoff, Prolog, Adobe Creative Suite, CMiC, Construction Management, Contract Management, Change Orders, Cost Accounting, E1, Submittals, RFI, HTML, Maximo, MSEDB, Construction, Primavera P6, Procurement, Subcontracting, MS Project, Project Estimation, Value Engineering, Microsoft Project
Education
North Carolina State University 1999 — 2005
BS
NSF October 2014 - Present
Validant March 2013 - December 2013
Novartis Consumer Health January 2012 - October 2012
Sandoz, Austria November 2011 - December 2011
Sandoz, B August 2011 - November 2011
NNE Pharmaplan June 2010 - May 2011
Bayer HealthCare October 2004 - October 2009
Bayer HealthCare July 2003 - September 2004
Bayer HealthCare January 2002 - June 2003
Bayer HealthCare January 1992 - December 2001
Skills
Change Control, GLP, Sop, Data Analysis, Biotechnology, Aseptic Processing, Quality Control, Auditing, Quality Management, Validation, Biopharmaceuticals, Technology Transfer, FDA, Inspection, Continuous Improvement, GMP, Software Documentation, Root Cause Analysis, CAPA, Laboratory, Quality System, Manufacturing, ISO 13485, Medical Devices, Assay Development, GAMP, Regulatory Requirements, Lifesciences, Management, Biochemistry, Quality Assurance, Testing, GCP, LIMS, Cross-functional Team..., Pharmacovigilance, Vaccines, ELISA, GxP, Regulatory Submissions, Six Sigma, Cleaning Validation, 21 CFR Part 11, Training, Pharmaceutical Industry, Quality Auditing, ISO, Internal Audit, Lean Manufacturing, Process Improvement
Education
Gujarat University 1971 — 1975
Bachelor of Science, Microbiology
CRB May 2015 - Present
NNE Pharmaplan August 2014 - May 2015
M+W Group June 2011 - July 2014
Yonkers Industries, Inc. January 2011 - June 2011
CH2MHILL March 2003 - December 2010
DuPont 1997 - 2000
Skills
Project Management, Instrumentation, Automation, FDA GMP, Process Safety..., Pressure Vessels, Root Cause Analysis
Education
Inter-American University of Puerto Rico-Metropolitan Campus 2003 — 2005
Master of Business Administration (MBA), Finance, General
University of Puerto Rico-Mayaguez 1991 — 1996
Bachelor of Science (BS), Electrical and Electronics Engineering
NNE Pharmaplan Design DrafterMelling EngineeringOctober 2013 - March 2015
Mid South Engineering November 2012 - October 2013
Stanford and White March 2012 - September 2012
Walker Engineering February 2011 - February 2012
Freedom group March 2010 - October 2010
Design Surfaces November 2007 - May 2009
Skills
Revit, SketchUp, AutoCAD, 3D Studio Max, Illustrator, ArcMap, Modeler, Rendering, BIM, CAD, Submittals, 3D rendering, 3D visualization, 3D, Microstation
Education
North Carolina Agricultural and Technical State University 2002 — 2007
BS, Computer Aid Design and Drafting
DSM Biomedical February 2014 - April 2015
GlaxoSmithKline 2003 - 2013
NNE Pharmaplan 1999 - 2003
Skills
Computer System..., GMP, 21 CFR Part 11, Change Control, Validation, Biopharmaceuticals, Pharmaceutical Industry, FDA, V&V, CAPA, Aseptic Processing, Cleaning Validation, SOP development, SOP authoring, Project Management, Utility Validation, Bioreactor Validation, Process Equipment, GxP, Quality Systems, R&D, Manufacturing, Technical Writing, Biotechnology, GAMP, Purification, Quality System
Education
Penn State University 1993 — 1998
B.S., Chemical Engineering
Cisco Systems June 2014 - Present
American Panel Corporation June 2013 - June 2014
NNE Pharmaplan June 2012 - May 2013
American Panel Corporation March 2007 - June 2012
American Panel Corporation August 2002 - March 2007
Tellabs October 2001 - May 2002
Nortel Networks 1998 - 2001
Skills
MES, Lean Manufacturing, Engineering, Integration, PMP, SCADA, SPC, Six Sigma
Education
Georgia State University - J. Mack Robinson College of Business 2002 — 2006
MBA, Marketing
Georgia Institute of Technology 1995 — 1998
BS, Electrical Engineering
Lyceum 1992 — 1995
IPS June 2011 - Present
NNE Pharmaplan August 2009 - March 2011
CRB Consulting Engineers November 2001 - May 2009
BE&K 1997 - 2001
Black & Veatch 1995 - 1997
Skills
Biotechnology, Cell Culture, Fermentation, Pharmaceutics, Biopharmaceuticals, Process Equipment, GMP, Chemical Engineering, Aseptic Processing, Process Engineering, Process Optimization, 21 CFR Part 11, P&ID, CAPA, Quality System, Sop, Pharmaceutical Industry, GAMP, Quality Assurance, Cleaning Validation, Filtration, GxP, Chromatography, Process Design
Education
North Carolina State University 1989 — 1994
BSCHE, Chemical Engineering
NNE Pharmaplan November 2014 - Present
Nova Southeastern University May 2013 - December 2014
Actavis 2009 - May 2013
Teva Pharmaceuticals 2005 - 2009
Enthalpy Analytical 1998 - 2005
Skills
GLP, HPLC, Analytical Chemistry, Pharmaceutical Industry, Chromatography, Sop, Wet Chemistry, GMP, Technology Transfer, UV/Vis, LIMS, Dissolution, FDA, V&V, Gas Chromatography, FTIR, Validation, Biotechnology, IR, Method Development, Assay Development, Laboratory, TLC
Education
Nova Southeastern University
MBA, Global Management
Hiram College
Bachelor of Arts (BA), Chemistry (ACS Certified), Philosophy
Lean Six of Eastern North Carolina September 2008 - Present
NNE Pharmaplan 2008 - November 2010
Metrics, Inc. February 1996 - January 2006
Industrial and Environmental Analysts, Inc. 1988 - 1990
Education
East Carolina University 1993 — 1996
B.S., Chemistry
NNE Pharmaplan May 2013 - Present
North Carolina State University August 2011 - Present
NCSU Industrial Extension Service May 2011 - August 2011
Alcatel-Lucent August 2009 - December 2009
Alcatel-Lucent January 2009 - May 2009
Southern Company May 2008 - August 2008
Skills
Solidworks, Industrial Engineering, Simulations, Six Sigma, AutoCAD, Engineering, JMP, Lean Manufacturing, Microsoft Office, Statistics, Java, Microsoft Excel, Project Management, Manufacturing, Process Improvement, Data Analysis, PowerPoint, Microsoft Word, Process Engineering, FactoryTalk View, FactoryTalk Historian, PLC Programming, HMI Design
Education
North Carolina State University 2011 — 2013
Master's, Industrial & Systems Engineering
North Carolina State University 2007 — 2011
BS, Industrial & Systems Engineering
NNE Pharmaplan June 2014 - Present
Kayem Foods Inc. January 2013 - August 2013
New England Controls January 2012 - June 2012
Bristol-Myers Squibb January 2011 - July 2011
Skills
P&ID, cGMP, Quality System..., Preventive Maintenance, FDA GMP, Biotechnology, Water Treatment, Process Engineering, Root Cause Analysis, CAPA, Change Control, 21 CFR Part 11, SOP, Microsoft Visio, Automation, Ultrafiltration, Scale Up, Reverse Osmosis, AutoCAD, SAP, Maximo
Education
Northeastern University 2009 — 2014
BS
NNE Pharmaplan 2014 - Present
Merck Sharp & Dohme 2010 - Present
Mixing & Mass Transfer Technologies LLC November 2009 - February 2010
Skills
Validation, GMP, Chemical Engineering, Technology Transfer, V&V, R&D, Process Simulation, Small Molecules, Biologics, Design of Experiments, Lean Manufacturing, Statistical Data..., Deviation Management, Process Improvement, Scale Up
Education
Penn State University 2005 — 2009
Bachelor of Science (B.S.), Chemical Engineering
Penn State University 2005 — 2009
Minor In Environmental Engineering
NNE Pharmaplan June 2014 - Present
Irod January 2004 - Present
M+W Group June 2011 - April 2014
Parsons November 2007 - May 2011
Wilson Architects Inc. January 2006 - September 2007
Mohar Design January 2005 - January 2006
Daniel Architects Inc. April 2000 - August 2004
Skills
Lifesciences, Pharmaceutical Industry, Graphical illustration..., Building Materials, Building Codes, Architectural Design, 3D Modeling, 3D rendering, Motion Design, Augment RV, Educational Technology, Healthcare Information..., Logistics, Environmental..., Disaster Response, Process Simulation, Laboratory, Parametric Modeling, Painting, Software Architectural...
Education
Central Institute for Design and Town Planning, Moscow, Russia 1987 — 1991
Post Graduate, Urbnan Design, 1990
Kyiv National University of Culture and Arts 1978 — 1984
Master's Degree, Architecture, 1984
NNE Pharmaplan February 2012 - Present
NNE Pharmaplan February 2012 - Present
Skills
Research, Teaching, Data Analysis, Analysis, Editing, English, C++, C#, MES, PharmaSuite, Microsoft SQL Server, VBA, Consulting, Manufacturing IT, Java, Matlab, Discrete Event..., Customer Service, Science
Education
Rice University 2002 — 2007
Doctor of Philosophy (Ph.D), Physics
University of North Carolina at Chapel Hill 1998 — 2002
Bachelor of Science (B.S.), Physics
NNE Pharmaplan May 2014 - Present
Hospira May 2012 - May 2014
Skills
Problem Solving, Project Execution, Time Management, Excel, Aspen Plus, Chemical Engineering, GMP, Process Engineering, Design of Experiments, Data Analysis, Technical Writing, Chemistry, Microsoft Office, PowerPoint, Statistics, Microsoft Word, Trackwise, Pharmaceutical Industry
Education
North Carolina State University
BS, Chemical Engineering, Magna Cum Laude
Roche April 2013 - Present
BD April 2012 - April 2013
Slate Pharmaceuticls August 2011 - January 2012
NNE Pharmaplan February 2010 - February 2011
Johnson Controls February 2009 - December 2009
Talecris Plasma Resources May 2007 - February 2009
Kelly Scientific Resources May 2006 - May 2007
Leiner Health Products May 2005 - May 2006
bioMerieux July 2004 - May 2005
Holopack International May 2001 - July 2004
Skills
Quality System, CAPA, 21 CFR Part 11, FDA, ISO 13485, Change Control, Validation, LIMS, Trackwise, GMP, Sop, GLP, Design Control, GxP, Regulatory Affairs, Biotechnology, Pharmaceutical Industry, Quality Auditing, Quality Assurance, Quality Control, Microbiology, Regulatory Requirements, FDA GMP, 21 CFR, Root Cause Analysis, GAMP, Risk Management, FMEA, STATURE
Education
Livingstone College
Bachelors of Science, Biology
Livingstone College
BS, Biology, General
Novozymes March 2014 - Present
NNE Pharmaplan April 2009 - February 2014
Skills
DCS, PLC, Instrumentation, SCADA, Process Automation, ABB 800xA, ABB SattLine, Commissioning, FAT/SAT, Automation, Control Logic, HMIs, Process Control, WinCC, PLC Programming, iFix, PCS7, Fieldbus, Calibration, RTU, Control Valves, Process Engineering
Education
Tianjin University of Technology 2000 — 2009
Master's degree, Automation Engineer Technology/Technician