NNE Pharmaplan
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NNE Pharmaplan Employees
Argos Therapeutics April 2015 - Present
Independent Validation Professional 2007 - Present
NNE Pharmaplan October 2013 - October 2014
ValSource, LLC February 2010 - March 2011
KBR, Inc. (formerly BE&K BioPharm) June 2007 - February 2009
PerkinElmer 2005 - 2006
Microbac Laboratories, Inc. (formerly Southern Testing & Research Labs) August 2000 - October 2004
Skills
Analytical Chemistry, 21 CFR Part 11, Validation, HPLC, Gas Chromatography, TOC, Commissioning, Laboratory Equipment, GMP, Sop, Change Control, FDA, LIMS, V&V, Pharmaceutical Industry, OOS, Water for Injection, Ion Chromatography, Chromatography Data..., UV/Vis, APIs, HEPA Filtration, Quality Assurance, Temperature Mapping, Clean Rooms, Biotechnology, Solid Oral Dosage Forms, Purified Water, User Requirements, IQ/OQ/PQ, CAPA, P&ID, Autoclave, Wet Chemistry, Kaye Validator, Compliance Remediation, Computer System..., Aseptic Processing, Quality Control, Chemistry, USP, Sterilization, Chromatography, Laboratory, GxP, Calibration, Parenteral, Dissolution, Analytical Method..., Technology Transfer
Education
University of Central Oklahoma 1995 — 1999
B.S., Forensic Science
Northern Oklahoma College 1993 — 1996
A.A., Social Science
Perry H.S.
Perry H.S.
MENTOR Technical Group Corporation May 2014 - Present
Mirus Consulting Group December 2012 - May 2014
Validation & Engineering Group, Inc. June 2007 - September 2012
NNE Pharmaplan November 1995 - May 2007
Skills
Business Process, Validation
Education
Universidad del Turabo 2011 — 2014
Bachelor of Business Administration (B.B.A.), Computerized Information System
Universidad de Puerto Rico 1990 — 1993
Associate's degree in Office Administration
NNE Pharmaplan August 2014 - Present
Merck January 2011 - August 2014
Abbott May 2010 - August 2010
Genencor, A Danisco Division August 2009 - May 2010
Asahi Kasei Bioprocess May 2009 - December 2009
Skills
Cleaning Validation, Sterilization, Process Qualification, Chemical Engineering, GMP, PI Processbook, SAP ERP, Microsoft Office, Biotechnology, Cross-functional Team..., Technology Transfer, CAPA, Six Sigma, Pharmaceutical Industry, SOP, Manufacturing, Process Simulation, Change Control, Validation, FDA
Education
University of Iowa 2006 — 2010
B.S.E., Chemical Engineering, 3.27
NNE Pharmaplan July 2011 - Present
Skills
Project Engineering, Engineering, Commissioning, Manufacturing, Project Management, Construction Management, Construction, Pharmaceutical Industry, GMP, Biotechnology
Education
University of North Carolina at Chapel Hill 1997 — 2000
Master of Business Administration (M.B.A.), Management Systems
University of New Hampshire 1977 — 2000
Bachelor's degree, Electrical Engineering
IPS-Integrated Project Services, Inc. October 2014 - Present
Integrated Project Services September 2011 - September 2014
NNE Pharmaplan April 2010 - September 2011
KBR, Inc. June 2006 - March 2010
Bristol-Myers Squibb June 2005 - August 2005
Skills
Process Design, Team Leadership, Process Simulation, Process Engineering, Process Optimization, Modeling, Biochemical Engineering, Chemical Engineering, Validation, Fermentation, GMP, Bioreactor, Technology Transfer, Biotechnology, Aseptic Processing, HAZOP, Commissioning, FDA, Biopharmaceuticals, P&ID, R&D, Engineering, Manufacturing, Chromatography, Aspen HYSYS, Change Control, Filtration, Aspen Plus, Process Control, CAPA, GAMP, 21 CFR Part 11, Sop, Design of Experiments
Education
University of Delaware - Lerner College of Business and Economics 2007 — 2009
MBA, Busniess Administration
University of Delaware 2002 — 2006
BCHE, Chemical Engineering
University of Delaware 2002 — 2006
Chemical Engineering
Christian Brothers Academy 1998 — 2002
Christian Brothers Academy 1998 — 2002
NNE Pharmaplan October 2014 - Present
Amway January 2011 - October 2014
Amway June 2005 - December 2010
Skills
Information Technology..., MES, Manufacturing..., Manufacturing, Pharmaceutical Industry, Cross-functional Team..., Continuous Improvement, Lean Manufacturing, Six Sigma, GMP, Product Development, Quality System, Kaizen, Supply Chain Management, Process Improvement, Root Cause Analysis, Supply Chain, SPC, R&D, Engineering, Project Management
Education
University of California, San Diego 2003 — 2008
Chemical Engineering B.S., Materials Science
NNE Pharmaplan March 2015 - July 2015
Oxford Global Resources June 2014 - October 2014
Thermo Fisher Scientific October 2013 - December 2013
Consulting through Validant January 2013 - June 2013
Quintiles May 2012 - August 2012
Pfizer Pharmaceuticals April 2011 - April 2012
L. Perrigo September 2010 - May 2011
Prudential Financial March 2009 - July 2010
MPI Research November 2007 - December 2008
MPI Research August 2006 - November 2007
Skills
Quality Assurance, Validation, Change Control, Sop, Quality System, Software Documentation, LIMS, Regulatory Affairs, Computer System..., 21 CFR Part 11, FDA, GMP, Pharmaceutical Industry, Quality Control, CRO, Toxicology, Laboratory, V&V, Lifesciences, CAPA, Technology Transfer, HPLC, SOP
Education
State University of New York College at Brockport 1972 — 1976
Bachelor of Science
NNE Pharmaplan August 2009 - Present
Lee Air Conditioners April 2007 - August 2009
Air Path (formaly Mazza PE) March 1998 - August 2006
Skills
Test Adjust and Balance, retro commissioning, Clean Room Performance..., Building pressure..., ISO, GMP, biological safety..., Testing, Clean Rooms, Commissioning, Quality Assurance, Quality System
Education
Suffolk County Community College
Belimed inc. February 2009 - Present
ISPE 2003 - Present
ISPE 1980 - Present
NNE Pharmaplan July 2008 - January 2009
Pharmadule April 2003 - June 2008
Getinge 1980 - 2003
American Sterilizer (AMSCO) 1992 - 1995
Education
TUI University 2000 — 2006
Ph.D., Business Administration - Marketing
Bristol-Myers Squibb March 2014 - Present
Enterprise System Partners Limited August 2013 - August 2014
Valspec June 2012 - July 2013
Emerson Process Management November 2011 - June 2012
NNE Pharmaplan November 2008 - November 2011
Robert E. Mason Company August 2006 - June 2008
Cornerstone Controls October 2005 - February 2006
Coneco de Puerto Rico August 2003 - July 2005
Skills
Automation, PLC, WebDAV, Process Automation, DCS, Control Systems Design, Validation, Commissioning, Process Control, MES, GMP, Testing, V&V, Instrumentation, GAMP, Fieldbus, SCADA, Emerson DeltaV, Control Logic, Profibus, Allen Bradley, HMIs
Education
Universidad de Puerto Rico 1997 — 2003
BS Electrical Engineering, Control System Engineering
NNE Pharmaplan September 2013 - Present
Merck Sharp & Dohme June 2010 - September 2013
Cook Pharmica October 2007 - May 2010
Amgen Manufacturing Limited 2005 - 2007
Skills
Biopharmaceuticals, GMP, Aseptic Processing, Filtration, Biotechnology, Sop, Validation, Fermentation, Technology Transfer, V&V, Chromatography, CAPA, FDA, Change Control, Cell Culture, Aseptic Technique, Purification, Cleaning Validation, 21 CFR Part 11, Protein Purification, Trackwise, Formulation, LIMS, Cell, Vaccines, cGMP manufacturing, MES, GLP, CIP, Deviations, SOP, TrackWise, Quality System, Computer System..., GxP
Education
The Johns Hopkins University 2007 — 2010
Masters of Science, Biotechnology
Universidad de Puerto Rico 2000 — 2005
Bioengineering, Industrial Biotechnology
Robins & Morton April 2013 - Present
NNE Pharmaplan November 2009 - April 2013
KBR, Inc. June 2002 - November 2009
CRB Consulting Engineers 1995 - 2001
Jacobs 1990 - 1995
C.E. Bailey & Associates, Inc. June 1986 - February 1990
Skills
AutoCAD, Project Management, Arc Flash, Electrical Estimating, Electrical Engineering, Electrical Distribution..., Fire Alarm, SKM PowerTools, Electrical Code, Technical Training, Area Classification, Technical Writing, Lighting Design, Power Distribution, Power System Studies, Commissioning, Construction, Power Systems, Electricity, Transformer, CAD, Engineering, Project Engineering, PLC, Manufacturing, Construction Management, DCS, Automation, Electricians, Microstation, Switchgear, Engineering Design, P&ID, Allen Bradley, Instrumentation
Education
University of Central Florida 1983 — 1986
BSEE, Electrical Engineering
Captain Advisory October 2014 - Present
Continuent June 2014 - October 2014
Auctive, Inc. June 2013 - June 2014
Sagence Group Inc. October 2012 - March 2013
NNE Pharmaplan June 2011 - September 2011
UCLA Health System October 2009 - February 2011
Skills
Research, Microsoft Excel, Analytics, Data Analysis, Statistics, Management Consulting, Medical Devices, Process Improvement, Data Management, Leadership, Market Research, Financial Modeling, Project Management, Cross-functional Team..., Economics, Analysis, Business Analysis, Data Mining, Business Strategy, Management, Financial Analysis
Education
University of California, Los Angeles 2008 — 2012
Bachelor of Arts (B.A.), Economics
Miramonte High 2004 — 2008
4.0
Movilitas Consulting EU May 2014 - Present
NNE Pharmaplan March 2005 - April 2014
NNE Pharmaplan March 2009 - January 2011
NNE Pharmaplan March 2005 - March 2009
Advantage Industrial Automation 2003 - 2005
Camstar Systems, Inc. 2000 - 2003
Camstar Systems, Inc. 2001 - 2002
Camstar Systems, Inc. 2000 - 2001
Vitex, Inc. 1998 - 2000
Bank of America 1996 - 1998
Skills
Direct Sales, Global Account..., Global Marketing, Sales Management, Salesforce.com, Sales Operations, International Business, International Sales, Account Management, Event Management, MES, Marketing Communications, Corporate Communications, Biotechnology, Marketing Strategy, Strategic Sales, Strategy, Management, Business Development, Marketing, Lifesciences, Product Marketing, Pharmaceutical Industry, FDA, Sales, New Business Development, Proposal Writing, Serialization, Building High..., Manufacturing Execution..., Leadership, Business Strategy, Product Development, CRM, Project Management, Manufacturing, Business Intelligence, Management Consulting, Cross-functional Team..., SaaS, Medical Devices, GMP, Consulting, Strategic Planning, Life Sciences, Integration
Education
University of North Carolina at Chapel Hill
BA, English
Boehringer Ingelheim November 2012 - Present
NNE Pharmaplan August 2009 - November 2012
Finesse Solutions, LLC February 2007 - June 2009
Emerson Process Management November 2001 - November 2004
Control Dynamics May 1997 - November 2001
Skills
Process Automation, Automation, DCS, GAMP, WebDAV, Validation, Process Control, Computer System..., Engineering, FDA, MES, PLC
Education
The University of Texas at Austin 1991 — 1995
BS, Chemical Engineering, Classical Civilization
NNE Pharmaplan March 2014 - Present
M+W Group November 2010 - March 2014
SSOE Group December 2008 - September 2010
OWP/P 2006 - 2008
The Austin Co / Austin AECOM 1997 - 2006
Abbott Laboratories 1988 - 1996
Skills
Architectural Design, Architects, Construction, NCARB, LEED AP, Comprehensive Planning, Renovation, Facilities Management, Project Planning, Budgets, Construction Drawings, Engineering, Sustainable Design, Construction Management, LEED, Submittals, AutoCAD, Proposal Writing, Feasibility Studies, Green Building, BIM
Education
University of Michigan
Master of Architecture
University of Alaska Anchorage
University of Michigan
Bachelor of Science
St. Thomas HS, Ann Arbor
MAP Pharmaceuticals 2011 - 2014
NNE Pharmaplan March 2010 - August 2011
Novo Nordisk Delivery Technologies September 2006 - April 2008
Albany Molecular Research November 2002 - August 2006
Procter & Gamble 1994 - 2000
Skills
21 CFR Part 11, Analytical Chemistry, Aseptic Processing, Biopharmaceuticals, Biotechnology, Change Control, Cleaning Validation, Clinical Trials, Computer System..., Continuous Improvement, Cross-functional Team..., Design of Experiments, FDA, FMEA, GAMP, GMP, GxP, HPLC, ISO, ISO 13485, LIMS, Lean Manufacturing, Lifesciences, Manufacturing, Pharmaceutical Industry, Process Simulation, Quality Assurance, Quality Control, Quality Management, Quality System, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Root Cause Analysis, SPC, Six Sigma, Software Documentation, Sop, V, Validation, CAPA, GLP, Chromatography, Clinical Development, R&D, Design Control, Medical Devices, Technology Transfer, Quality Auditing, Process Improvement
Education
State University of New York College at Plattsburgh
BS, Chemistry
Castle Hill Technologies November 2013 - Present
REDROC INC. April 2006 - October 2013
NNE Pharmaplan July 2004 - April 2006
IPS Validation September 2003 - June 2004
CRB Consulting Engineers April 1999 - September 2003
Applied Systems Technology July 1990 - April 1999
Tangram Enterprise Solutions April 1994 - February 1996
Skills
Validation, Change Control, 21 CFR Part 11, Schedules, Project Management, Computer System..., FDA, GMP, Biopharmaceuticals, CAPA, Aseptic Processing, Pharmaceutical Industry, Sop, V&V, GxP, Quality Assurance, GAMP, Cleaning Validation, Quality System, Pharmaceutics, Biotechnology, GLP, Medical Devices, Commissioning, Lifesciences, Technology Transfer, Quality Control, Quality Management, Software Documentation, Quality Auditing, ISO 13485, Process Simulation, Chromatography, Process Engineering, Regulatory Affairs
Education
University of North Carolina at Pembroke 1986 — 1987
Process Design Solutions July 2009 - Present
Shire HGT July 2009 - December 2013
NNE Pharmaplan October 2007 - July 2009
Wyeth Biotech September 2006 - September 2007
Wyeth BioPharma 2001 - 2006
Skills
FDA, GMP, Fermentation, Technology Transfer, Biopharmaceuticals, Validation, Filtration, CAPA, Aseptic Processing, Biotechnology, V&V, Purification, Cell Culture, Change Control, Chromatography, Sop, Downstream Processing, Pharmaceutical Industry
Education
Tufts University 2004 — 2008
ME, Biotechnology Engineering
University of Massachusetts, Amherst 1997 — 2001
BS, Microbiology
NNE Pharmaplan June 2011 - Present
Baxter Healthcare May 2010 - May 2011
Novartis February 2009 - April 2010
Emerson Process Management February 2007 - December 2008
Global Automation Partners July 2006 - February 2007
Eli Lilly (Contractor) 1999 - 2006
Zenith Technologies 2002 - 2003
Advanced System Integrator February 1997 - September 1999
Jager Engineering 1995 - 1997
Canadian Forest Products 1992 - September 1995
Skills
Visual Basic, Process Automation, DCS, WebDAV, Emerson DeltaV, Process Control, SCADA, Automation, Control Systems Design, Commissioning, Validation, Testing, iFix, Process Engineering, Process Simulation, Allen Bradley, Engineering, Instrumentation, Allen-Bradley
Education
The University of British Columbia
Bachelor of Engineering (B.Eng.), Mechanical Engineering - Computer Aided Automation
The University of British Columbia 1988 — 1992
Engineering, Mechanical (Computer Aided Automation)
Avid Solutions January 2013 - Present
Grifols November 2008 - January 2013
Code Works LLC November 2007 - November 2008
NNE Pharmaplan May 2004 - April 2007
CDI September 2002 - December 2003
Minntech Corporation February 1999 - September 2002
Wunderlich-Malec Engineering August 1997 - February 1999
Skills
GAMP, Process Automation, Automation, Commissioning, Allen Bradley, Project Engineering, Control Systems Design, DCS, Validation, Computer System..., Wonderware, Instrumentation, PLC, SCADA, Process Control, Pharmaceutical Industry, HMIs, Control Logic, Integration, RSLogix, Engineering, WebDAV, PLC Programming, Profibus, 21 CFR Part 11, DeviceNet, Industrial Control, Modbus, MES, Change Control, Emerson DeltaV, V&V, Process Simulation, GxP, Testing, GMP
Education
University of St. Thomas - Opus College of Business 1998 — 2000
The University of Kansas 1984 — 1988
BS, Electrical and Computer Engineering
Genzyme December 2013 - Present
Superior Controls February 2013 - December 2013
NNE Pharmaplan October 2012 - February 2013
Lonza January 2011 - November 2012
Genzyme October 2009 - February 2011
Genzyme September 2001 - October 2010
BFGoodrich 1993 - August 2001
Sanncor Industries November 1987 - December 1993
Skills
Emerson DeltaV..., Allen Bradley PLC and..., Emerson RS3, OSIsoft PI..., cGMP manufacturing, Instrumentation &..., Configurations, Equipment Maintenance, Emerson DeltaV, Instrumentation, Allen Bradley, Commissioning, Automation, WebDAV, DCS, GAMP, PLC, Validation, Process Automation
Education
University of Mississippi 1982 — 1986
BS Chemical Engineering, Chem Eng.
PP Manufacturing Corp. January 2011 - Present
QSI January 2009 - Present
Shire HGT 2010 - 2011
NNE Pharmaplan 2006 - 2009
Biopure 2006 - 2006
BioMetics 1997 - 2004
Oravax, Inc. 1995 - 1997
Repligen Corporation 1991 - 1995
Applied BioTechnoogy 1988 - 1991
Collaborative Research, Inc. 1987 - 1988
Education
University of Massachusetts Lowell 1987 — 2000
MS, Biological Sciences
University of Massachusetts Lowell 1983 — 1987
BS, Biological Sciences
UBS Investment Bank June 2015 - Present
NNE Pharmaplan May 2011 - July 2014
Merck June 2008 - April 2011
Skills
Biotechnology, Pharmaceutical Industry, Automation, Validation, Manufacturing, Computer System..., GAMP, GMP, Emerson DeltaV, 21 CFR Part 11, Financial Modeling, Lifesciences, Change Control, GxP, Valuation, Biopharmaceuticals, CAPA, FDA, Microsoft Office, Microsoft Excel, V&V, Technology Transfer, Matlab, Life Sciences, Microsoft Word, Excel, Pharmaceuticals, Problem Solving, Word
Education
New York University - Leonard N. Stern School of Business 2014 — 2016
Master of Business Administration (MBA), Finance, Strategy, Business Analytics
University of Pennsylvania 2004 — 2008
BSE, Bioengineering, Economics
Qualitest Pharmaceuticals July 2015 - Present
G&W Laboratories June 2014 - July 2015
Actavis April 2012 - June 2014
Actavis January 2007 - March 2012
NNE Pharmaplan November 2005 - January 2007
Stelex - The Validation Group May 2004 - September 2005
Skills
Technology Transfer, V&V, CAPA, Validation, GMP, Change Control, Investigation, 21 CFR Part 11, GxP, GAMP, Quality System, Sop, Quality Auditing, Pharmaceutical Industry, Cleaning Validation, Quality Assurance, FDA, SOP
Education
University of South Carolina - Darla Moore School of Business 2011 — 2015
Master's degree, Business Administration and Management, General
University at Buffalo 2001 — 2003
Bachelor's degree, Chemical Engineering
PPS Engineers, Inc. October 2010 - Present
NNE Pharmaplan 2009 - 2010
Building and Earth Sciences 2006 - 2009
Skills
Technology Transfer, FDA, Biopharmaceuticals, Pharmaceutical Industry, Biotechnology, GMP, Validation, V&V, Quality System, Sop, Quality Assurance, Medical Devices, 21 CFR Part 11, CAPA, Lifesciences, Computer System..., Regulatory Affairs, LIMS, Quality Auditing, Clinical Trials, Process Simulation, Quality Control, R&D, Process Optimization, Process Engineering, Quality Management, ISO, Process Control, Commissioning, Engineering Management, Engineering Design, Engineering, Piping, Management, Project Engineering
Education
The University of Tennessee at Chattanooga
BS, Engineering
University of North Carolina at Charlotte
Masters, Business Administration - Finance
NNE Pharmaplan 1998 - Present
Bermudez & Longo 1997 - 1998
FEMA 1995 - 1997
Skills
Validation, GAMP, Process Engineering, GMP, V&V, 21 CFR Part 11, Pharmaceutical Industry, Quality Engineering, Control System..., Technical Writer, P&ID Walkdowns, Quality Management..., FDA, Quality Control, Engineering, Commissioning, Change Control, Sop
Education
Universidad del Turabo 1991 — 1995
Bachelor of Science degree, Mechanical Engineering
Universidad Metropolitana, Puerto Rico 1989 — 1991
Computer Science
NNE Pharmaplan March 2010 - Present
Excelsus Scientific Engineering December 2006 - January 2010
Memory Pharmaceuticals June 1999 - September 2006
National Institutes of Health February 1998 - May 1999
Skills
GMP, Change Control, Biotechnology, Pharmaceutical Industry, Quality System, Lifesciences, R&D, Quality Risk Management, Validation, Biopharmaceuticals, V&V
Education
The Ohio State University
Ph.D., Neuroscience/Physiology
NNE Pharmaplan November 2009 - January 2015
BE&K Engineering of NC April 2001 - October 2009
Lockwood Greene July 1999 - April 2001
Skills
Fermentation, Biotechnology, 21 CFR Part 11, Pharmaceutical Industry, FDA, Lifesciences, Biopharmaceuticals, Aseptic Processing, Engineering, FDA GMP, Facility Development, Facility Assessment, Laboratory Design, Solid Oral Dosage Forms, Parenteral, Bulk API, Packaging, Medical Devices
Education
University of Washington 1980 — 1983
Master of Architecture (M.Arch.), Architecture
University of Colorado at Boulder 1977 — 1980
Bachelor of Environmental Design, Architecture