Valspec Company
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Valspec Employees
Employee
Years
Job
Industry
Jhamel Williams Jhamel Williams's Valspec Experience January 2014 - Present
Job Senior Lead Validation Engineer at VALSPEC
Industry Pharmaceuticals
Experience
VALSPEC January 2014 - Present
Bristol-Myers Squibb October 2012 - December 2013
Merck May 2009 - October 2012
ValSource, LLC June 2006 - May 2009
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Public Speaking, Automation, Change Control, Testing, Validation, Troubleshooting, 21 CFR Part 11, Biotechnology, CAPA, FDA, Manufacturing, PLC, Pharmaceutical Industry, SOP
Education
Campbell University 2000 — 2005
Bachelor of Science (BS), Pharmaceutical Sciences
VALSPEC January 2014 - Present
Bristol-Myers Squibb October 2012 - December 2013
Merck May 2009 - October 2012
ValSource, LLC June 2006 - May 2009
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Public Speaking, Automation, Change Control, Testing, Validation, Troubleshooting, 21 CFR Part 11, Biotechnology, CAPA, FDA, Manufacturing, PLC, Pharmaceutical Industry, SOP
Education
Campbell University 2000 — 2005
Bachelor of Science (BS), Pharmaceutical Sciences
Willie Bynes Willie Bynes's Valspec Experience June 2012 - July 2012
Job Computer Facilitator
Industry Computer Software
Experience
Better Tomorrow's May 2014 - Present
Concilio August 2013 - May 2014
Insight Global February 2014 - March 2014
City Year August 2012 - June 2013
Valspec June 2012 - July 2012
Liberty Business Consulting, Inc. May 2012 - June 2012
Skills
Youth Development, Leadership, Community Service, Volunteer Management, Community Outreach, Youth Mentoring, Program Development, Tutoring, Training, Grant Writing, Nonprofits, Program Evaluation, Cross-functional Team..., Civic Engagement, After School Programs, Service Learning, Community Organizing, Education Policy, Positive Youth..., Event Planning, Social Networking, Microsoft Word, PowerPoint, Fundraising, Public Speaking, Teaching, Leadership Development, Curriculum Development, Microsoft Office, Microsoft Excel, Access, Customer Service, Mac, Analysis, Volunteering, Student Development, Academic Tutoring, Community Building, C++, Java
Education
Lincoln University 2008 — 2012
Bachelor of Science (B.S.), Computer Science
Lincoln University 2008 — 2012
Bachelor's Degree, Computer Science
Better Tomorrow's May 2014 - Present
Concilio August 2013 - May 2014
Insight Global February 2014 - March 2014
City Year August 2012 - June 2013
Valspec June 2012 - July 2012
Liberty Business Consulting, Inc. May 2012 - June 2012
Skills
Youth Development, Leadership, Community Service, Volunteer Management, Community Outreach, Youth Mentoring, Program Development, Tutoring, Training, Grant Writing, Nonprofits, Program Evaluation, Cross-functional Team..., Civic Engagement, After School Programs, Service Learning, Community Organizing, Education Policy, Positive Youth..., Event Planning, Social Networking, Microsoft Word, PowerPoint, Fundraising, Public Speaking, Teaching, Leadership Development, Curriculum Development, Microsoft Office, Microsoft Excel, Access, Customer Service, Mac, Analysis, Volunteering, Student Development, Academic Tutoring, Community Building, C++, Java
Education
Lincoln University 2008 — 2012
Bachelor of Science (B.S.), Computer Science
Lincoln University 2008 — 2012
Bachelor's Degree, Computer Science
Chris Relton Chris Relton's Valspec Experience September 2015 - Present
Job VP Sales at Invensys
Industry Industrial Automation
Experience
VALSPEC September 2015 - Present
Invensys/Schneider-Electric 2008 - August 2015
Invensys Operations Management April 2005 - April 2008
Invensys April 2002 - April 2005
Invensys July 1997 - July 2002
Skills
Direct Sales, Business Strategy, Petrochemical, International Sales, Process Automation, Sales Management, Solution Selling, Sales Process, Engineering, Automation, Sales, Management, Integration, Sales Operations, Project Management, Contract Negotiation, Process Control, Channel, Product Management, Strategy, Instrumentation, Strategic Planning, CRM, Key Account Management, Product Development, Enterprise Software, Channel Partners, Product Marketing, Competitive Analysis, SaaS, Go-to-market Strategy, Business Development, Start-ups, New Business Development, MES, Account Management, Cross-functional Team..., Manufacturing, P&L Management, Selling, Strategic Partnerships, Product Launch, Professional Services, Salesforce.com, Sales Presentations, Industrial Control, Complex Sales, B2B
Education
McGill University 1999 — 2001
MBA, International Finance/Marketing
McGill University 1982 — 1986
BEng, Mechanical Engineering
VALSPEC September 2015 - Present
Invensys/Schneider-Electric 2008 - August 2015
Invensys Operations Management April 2005 - April 2008
Invensys April 2002 - April 2005
Invensys July 1997 - July 2002
Skills
Direct Sales, Business Strategy, Petrochemical, International Sales, Process Automation, Sales Management, Solution Selling, Sales Process, Engineering, Automation, Sales, Management, Integration, Sales Operations, Project Management, Contract Negotiation, Process Control, Channel, Product Management, Strategy, Instrumentation, Strategic Planning, CRM, Key Account Management, Product Development, Enterprise Software, Channel Partners, Product Marketing, Competitive Analysis, SaaS, Go-to-market Strategy, Business Development, Start-ups, New Business Development, MES, Account Management, Cross-functional Team..., Manufacturing, P&L Management, Selling, Strategic Partnerships, Product Launch, Professional Services, Salesforce.com, Sales Presentations, Industrial Control, Complex Sales, B2B
Education
McGill University 1999 — 2001
MBA, International Finance/Marketing
McGill University 1982 — 1986
BEng, Mechanical Engineering
Anne Kriebel's Valspec Experience 2000 - 2013
Job Project Administrator at Proconex
Industry Industrial Automation
Experience
Proconex August 2000 - Present
VALSPEC 2000 - 2013
Micro-Coax, Inc. 1989 - 1998
Skills
Microsoft Excel, Microsoft Word, Alliance, NOMIS, Access, Oral & Written..., Project administration, Microsoft Project, Outstanding time..., Project Engineering, Computer System..., Quality Assurance, MS Project, Automation, Process Control, Process Automation, DCS, Project Managers, Engineering, Instrumentation, Management, Manufacturing, Process Engineering
Education
Montgomery County Community College 1984 — 1986
Associates Degree, Business Administration and Management, General
Proconex August 2000 - Present
VALSPEC 2000 - 2013
Micro-Coax, Inc. 1989 - 1998
Skills
Microsoft Excel, Microsoft Word, Alliance, NOMIS, Access, Oral & Written..., Project administration, Microsoft Project, Outstanding time..., Project Engineering, Computer System..., Quality Assurance, MS Project, Automation, Process Control, Process Automation, DCS, Project Managers, Engineering, Instrumentation, Management, Manufacturing, Process Engineering
Education
Montgomery County Community College 1984 — 1986
Associates Degree, Business Administration and Management, General
Wilfredo Santiago Wilfredo Santiago's Valspec Experience November 2012 - November 2013
Job Pharmaceuticals Consultant and Professional
Industry Pharmaceuticals
Experience
USDM Life Sciences November 2013 - Present
Valspec November 2012 - November 2013
Weil Group Inc. April 2003 - November 2012
Johnson & Johnson 2006 - 2010
C.I.Q.A. 2001 - 2003
Skills
Process Validation, Computer System..., Technical Writing, Data Analysis, 21 CFR Part 11, Validation, Quality Systems, Medical Devices, GAMP, CAPA, Change Control, SOP, GMP, FDA, Quality Assurance, GxP, Document Management, MES, LIMS, Documentation, Software Validation, Compliance, GLP, Environmental Monitoring, Microbiology, Testing, SDLC, Risk Management, Pharmaceuticals, Biotechnology, Cleaning Validation, ISO, ISO 13485, Manufacturing, Pharmaceutical Industry, Quality Control, Quality Management, Quality System, Six Sigma, Software Documentation, V&V, Regulatory Affairs, Technology Transfer, Quality Auditing, Sop
Education
Universidad de Puerto Rico 1995 — 2001
Bachelor's degree, Computer Science
USDM Life Sciences November 2013 - Present
Valspec November 2012 - November 2013
Weil Group Inc. April 2003 - November 2012
Johnson & Johnson 2006 - 2010
C.I.Q.A. 2001 - 2003
Skills
Process Validation, Computer System..., Technical Writing, Data Analysis, 21 CFR Part 11, Validation, Quality Systems, Medical Devices, GAMP, CAPA, Change Control, SOP, GMP, FDA, Quality Assurance, GxP, Document Management, MES, LIMS, Documentation, Software Validation, Compliance, GLP, Environmental Monitoring, Microbiology, Testing, SDLC, Risk Management, Pharmaceuticals, Biotechnology, Cleaning Validation, ISO, ISO 13485, Manufacturing, Pharmaceutical Industry, Quality Control, Quality Management, Quality System, Six Sigma, Software Documentation, V&V, Regulatory Affairs, Technology Transfer, Quality Auditing, Sop
Education
Universidad de Puerto Rico 1995 — 2001
Bachelor's degree, Computer Science
Laura Adamchak's Valspec Experience September 2013 - August 2015
Job Georgetown MBA 2017 | Pharmaceutical Product Management Focus | Validation Engineering | Biotechnology
Industry Pharmaceuticals
Experience
Merck October 2013 - August 2015
VALSPEC September 2013 - August 2015
Merrill Lynch June 2012 - August 2012
Mack's Pizza of Stone Harbor June 2006 - August 2012
Skills
Chemical Engineering, Time Management, Matlab, MathCAD, Microsoft Excel, Microsoft Word, Manufacturing, Aspen Plus, Software Documentation, Microsoft Office, Access
Education
Georgetown University - The McDonough School of Business 2015 — 2017
Master of Business Administration (M.B.A.)
Villanova University 2009 — 2013
Bachelor of Science (B.S.), Chemical Engineering, Bioengineering, Business
Tampa Preparatory School 2005 — 2009
High School Diploma
Merck October 2013 - August 2015
VALSPEC September 2013 - August 2015
Merrill Lynch June 2012 - August 2012
Mack's Pizza of Stone Harbor June 2006 - August 2012
Skills
Chemical Engineering, Time Management, Matlab, MathCAD, Microsoft Excel, Microsoft Word, Manufacturing, Aspen Plus, Software Documentation, Microsoft Office, Access
Education
Georgetown University - The McDonough School of Business 2015 — 2017
Master of Business Administration (M.B.A.)
Villanova University 2009 — 2013
Bachelor of Science (B.S.), Chemical Engineering, Bioengineering, Business
Tampa Preparatory School 2005 — 2009
High School Diploma
Carlisse Abreu Carlisse Abreu's Valspec Experience June 2011 - December 2012
Job Validation Engineer CSV
Industry Pharmaceuticals
Experience
Barry-Wehmiller Design Group January 2015 - Present
ACE Technologies, LLC January 2012 - October 2014
Eli Lilly and Company June 2013 - April 2014
Valspec June 2011 - December 2012
Pfizer November 2010 - May 2011
Abbott Laboratories December 2004 - September 2010
Skills
DeltaV, Validation, DCS, Computer System..., GMP, GDP, GxP, 21 CFR Part 11, PLC, FactoryTalk, HMIs, Parenteral, Packaging, Automation, VMS, GAMP, Change Control, MES, WebDAV, CAPA, FDA, Manufacturing, Quality System, SOP
Education
University of Puerto Rico
Bachelor, Chemical Engineering
Barry-Wehmiller Design Group January 2015 - Present
ACE Technologies, LLC January 2012 - October 2014
Eli Lilly and Company June 2013 - April 2014
Valspec June 2011 - December 2012
Pfizer November 2010 - May 2011
Abbott Laboratories December 2004 - September 2010
Skills
DeltaV, Validation, DCS, Computer System..., GMP, GDP, GxP, 21 CFR Part 11, PLC, FactoryTalk, HMIs, Parenteral, Packaging, Automation, VMS, GAMP, Change Control, MES, WebDAV, CAPA, FDA, Manufacturing, Quality System, SOP
Education
University of Puerto Rico
Bachelor, Chemical Engineering
Jennifer Katsigiannis's Valspec Experience January 2011 - June 2011
Job Compliance Specialist at PPL Corporation
Industry Utilities
Experience
PPL Corporation February 2015 - Present
Katsigiannis Consulting, LLC July 2014 - February 2015
Aerotek June 2011 - June 2014
VALSPEC January 2011 - June 2011
VALSPEC August 2010 - December 2010
Skills
PowerPoint, Access, Regulations, Compliance, Internal Audit, Quality Assurance, Microsoft Office, Microsoft Word, Microsoft Excel, Training, Auditing, Visio, NERC, Analysis, Power Generation, Leadership, Troubleshooting, Program Management, Energy, Management, Process Improvement
Education
Pennsylvania State University-Penn State Abington 1990 — 1997
BS, General Science
PPL Corporation February 2015 - Present
Katsigiannis Consulting, LLC July 2014 - February 2015
Aerotek June 2011 - June 2014
VALSPEC January 2011 - June 2011
VALSPEC August 2010 - December 2010
Skills
PowerPoint, Access, Regulations, Compliance, Internal Audit, Quality Assurance, Microsoft Office, Microsoft Word, Microsoft Excel, Training, Auditing, Visio, NERC, Analysis, Power Generation, Leadership, Troubleshooting, Program Management, Energy, Management, Process Improvement
Education
Pennsylvania State University-Penn State Abington 1990 — 1997
BS, General Science
Jeremy Lenhof Jeremy Lenhof's Valspec Experience February 2012 - Present
Job Validation Engineer at Valspec
Industry Design
Experience
Valspec February 2012 - Present
Baxter Healthcare July 2011 - February 2012
Cal Poly State University September 2009 - June 2010
General Atomics Electronic Systems Inc June 2008 - September 2009
Skills
Minitab, Scanning Electron..., Microsoft Excel, Delta V, Microsoft Word, Visual Basic 5.0/6.0, Computer System..., Validation, Validation Engineering, Validation IQ, Manufacturing, Engineering, R&D, Materials Science, Testing
Education
California Polytechnic State University-San Luis Obispo 2006 — 2010
B.S., Materials Engineering
Valspec February 2012 - Present
Baxter Healthcare July 2011 - February 2012
Cal Poly State University September 2009 - June 2010
General Atomics Electronic Systems Inc June 2008 - September 2009
Skills
Minitab, Scanning Electron..., Microsoft Excel, Delta V, Microsoft Word, Visual Basic 5.0/6.0, Computer System..., Validation, Validation Engineering, Validation IQ, Manufacturing, Engineering, R&D, Materials Science, Testing
Education
California Polytechnic State University-San Luis Obispo 2006 — 2010
B.S., Materials Engineering
Derek Bachmann's Valspec Experience June 2013 - Present
Job Resource Specialist at Valspec
Industry Staffing and Recruiting
Experience
Valspec June 2013 - Present
Yoh, A Day & Zimmermann Company July 2007 - June 2013
Global Employment Solutions July 2005 - May 2007
Ascensus 1999 - 2005
Education
Temple University
School of Communications
Valspec June 2013 - Present
Yoh, A Day & Zimmermann Company July 2007 - June 2013
Global Employment Solutions July 2005 - May 2007
Ascensus 1999 - 2005
Education
Temple University
School of Communications
Jack R. Seiple III Jack R. Seiple III's Valspec Experience June 2001 - April 2002
Job Scientist II at Teva Pharmaceuticals
Industry Pharmaceuticals
Experience
Teva Pharmaceuticals October 2014 - Present
Teva Pharmaceuticals March 2013 - Present
Teva Pharmaceuticals September 2011 - Present
Pfizer October 2009 - January 2010
Wyeth-Fort Dodge Animal Health January 2005 - October 2009
Wyeth-West Chester May 2002 - January 2005
VALSPEC June 2001 - April 2002
Wyeth-Ayerst Laboratories January 1995 - June 2001
Fisons Pharmaceuticals January 1992 - January 1994
Rochester Gas and Electric January 1991 - January 1992
Skills
Advanced Raman..., Transmission Raman, Pharmaceutical Forensics, HPLC, GC, ICPMS, Process Validation, Equipment Qualification, Computer Validation, GMP, Pharmaceutical Industry, Validation, FDA, SOP, GLP, 21 CFR Part 11, Change Control, Chromatography, Project Management
Education
Rochester Institute of Technology 1989 — 1994
BS, Chemistry
Rochester Institute of Technology
Bachelor of Science, Chemistry
Teva Pharmaceuticals October 2014 - Present
Teva Pharmaceuticals March 2013 - Present
Teva Pharmaceuticals September 2011 - Present
Pfizer October 2009 - January 2010
Wyeth-Fort Dodge Animal Health January 2005 - October 2009
Wyeth-West Chester May 2002 - January 2005
VALSPEC June 2001 - April 2002
Wyeth-Ayerst Laboratories January 1995 - June 2001
Fisons Pharmaceuticals January 1992 - January 1994
Rochester Gas and Electric January 1991 - January 1992
Skills
Advanced Raman..., Transmission Raman, Pharmaceutical Forensics, HPLC, GC, ICPMS, Process Validation, Equipment Qualification, Computer Validation, GMP, Pharmaceutical Industry, Validation, FDA, SOP, GLP, 21 CFR Part 11, Change Control, Chromatography, Project Management
Education
Rochester Institute of Technology 1989 — 1994
BS, Chemistry
Rochester Institute of Technology
Bachelor of Science, Chemistry
Brenda Dorwart Small Brenda Dorwart Small's Valspec Experience December 2011 - Present
Job Contract Automation Document Coordinator via Proconex at New England Controls
Industry Pharmaceuticals
Experience
VALSPEC December 2011 - Present
Novartis 2008 - January 2012
Wyeth 2005 - 2008
Essilor May 1986 - January 2005
Skills
Software Documentation, Validation, GMP, Sop, Adobe Acrobat, Manufacturing, 21 CFR Part 11, Computer System..., Automation, GAMP, Microsoft Office 2007, Document Management, Microsoft Excel, Pharmaceutical Industry, Change Control, GxP, CAPA, Biopharmaceuticals, Visio, Outlook, PowerPoint, Technical Writing, Quality Assurance, V&V, Lotus Notes, FDA, Quality System, LIMS, Trackwise, Adobe Acrobat..., SOP, Microsoft Office
Education
St. Petersburg College 1999 — 2001
Microsoft Office Specialist
VALSPEC December 2011 - Present
Novartis 2008 - January 2012
Wyeth 2005 - 2008
Essilor May 1986 - January 2005
Skills
Software Documentation, Validation, GMP, Sop, Adobe Acrobat, Manufacturing, 21 CFR Part 11, Computer System..., Automation, GAMP, Microsoft Office 2007, Document Management, Microsoft Excel, Pharmaceutical Industry, Change Control, GxP, CAPA, Biopharmaceuticals, Visio, Outlook, PowerPoint, Technical Writing, Quality Assurance, V&V, Lotus Notes, FDA, Quality System, LIMS, Trackwise, Adobe Acrobat..., SOP, Microsoft Office
Education
St. Petersburg College 1999 — 2001
Microsoft Office Specialist
Dale Witman Dale Witman's Valspec Experience September 2003 - December 2005
Job Automation Engineer at Natvar a division of TekniPlex, Inc.
Industry Medical Devices
Experience
Tekni-Plex, Inc. April 2015 - Present
Fres-co System USA, Inc. September 2013 - November 2014
Ai Control Systems April 2010 - September 2013
Avanceon September 2006 - April 2009
Sharp Corporation April 2006 - June 2006
Valspec September 2003 - December 2005
West Pharmaceutical Services September 1980 - November 2002
Wagner Electric March 1978 - May 1980
Skills
PLC, Wonderware, Commissioning, Validation, System Design, Packaging, Automation, ControlLogix, SCADA, DCS, Allen Bradley, Instrumentation, Electrical, Process Control, MES, Troubleshooting, Electronics, Electrical Engineering, Process Automation, Control System Design, AutoCAD, Manufacturing, Project Engineering, Sensors, User Interface, Integration, HMIs, Siemens S7, Inductive Automation..., Emerson DeltaV, Control Systems Design, GAMP, WebDAV, Industrial Control, Engineering, Control Logic, Motion Control, PLC Programming, DeviceNet, ControlNet, Profibus, Modicon, Industrial Ethernet, DH+, RSLogix, Ladder Logic, Process Engineering, Allen-Bradley
Education
Penn State University 1979 — 1985
Electrical Engineering
Ryder Technical Institute 1971 — 1974
Associate, Electronics
Tekni-Plex, Inc. April 2015 - Present
Fres-co System USA, Inc. September 2013 - November 2014
Ai Control Systems April 2010 - September 2013
Avanceon September 2006 - April 2009
Sharp Corporation April 2006 - June 2006
Valspec September 2003 - December 2005
West Pharmaceutical Services September 1980 - November 2002
Wagner Electric March 1978 - May 1980
Skills
PLC, Wonderware, Commissioning, Validation, System Design, Packaging, Automation, ControlLogix, SCADA, DCS, Allen Bradley, Instrumentation, Electrical, Process Control, MES, Troubleshooting, Electronics, Electrical Engineering, Process Automation, Control System Design, AutoCAD, Manufacturing, Project Engineering, Sensors, User Interface, Integration, HMIs, Siemens S7, Inductive Automation..., Emerson DeltaV, Control Systems Design, GAMP, WebDAV, Industrial Control, Engineering, Control Logic, Motion Control, PLC Programming, DeviceNet, ControlNet, Profibus, Modicon, Industrial Ethernet, DH+, RSLogix, Ladder Logic, Process Engineering, Allen-Bradley
Education
Penn State University 1979 — 1985
Electrical Engineering
Ryder Technical Institute 1971 — 1974
Associate, Electronics
Stephen Kelso's Valspec Experience October 2012 - April 2014
Job Automation Engineer at BarryWehmiller Design Group
Industry Pharmaceuticals
Experience
Barry-Wehmiller Design Group April 2014 - Present
Valspec October 2012 - April 2014
Clarkson University August 2007 - August 2012
Clarkson University IMPETUS August 2011 - May 2012
Clarkson University Swimming August 2011 - March 2012
Alcoa Technical Center May 2010 - August 2010
Exeter Recreation Dept. May 2004 - August 2009
Cannonball Swim November 2005 - 2009
Skills
Microsoft Word, PowerPoint, Microsoft Excel, Visual Basic, Matlab, UniSim, SuperPro Design, Risk Assessment, Monte Carlo Simulation, Financial Accounting, Accounting, Problem Solving, Delta V, Validation, Test Validation, Validation Engineering, Validation IQ, Validation Reports, Chemistry, Engineering, Materials Science, Chemical Engineering
Education
Emerson 2012 — 2012
Delta V Certified
Clarkson University 2011 — 2012
Graduate School, Environmental Engineering/Business, 3.2
Clarkson University 2007 — 2011
Chemical Engineering B.S.
Seacoast School of Technology 2004 — 2005
Barry-Wehmiller Design Group April 2014 - Present
Valspec October 2012 - April 2014
Clarkson University August 2007 - August 2012
Clarkson University IMPETUS August 2011 - May 2012
Clarkson University Swimming August 2011 - March 2012
Alcoa Technical Center May 2010 - August 2010
Exeter Recreation Dept. May 2004 - August 2009
Cannonball Swim November 2005 - 2009
Skills
Microsoft Word, PowerPoint, Microsoft Excel, Visual Basic, Matlab, UniSim, SuperPro Design, Risk Assessment, Monte Carlo Simulation, Financial Accounting, Accounting, Problem Solving, Delta V, Validation, Test Validation, Validation Engineering, Validation IQ, Validation Reports, Chemistry, Engineering, Materials Science, Chemical Engineering
Education
Emerson 2012 — 2012
Delta V Certified
Clarkson University 2011 — 2012
Graduate School, Environmental Engineering/Business, 3.2
Clarkson University 2007 — 2011
Chemical Engineering B.S.
Seacoast School of Technology 2004 — 2005
Natalie Diep Natalie Diep's Valspec Experience September 2012 - November 2014
Job Senior Automation Consultant at Sequoia Consulting Group, LLC
Industry Pharmaceuticals
Experience
Sequoia Consulting Group, LLC December 2014 - Present
Valspec September 2012 - November 2014
Baxter Bioscience May 2010 - August 2012
Baxter BioScience August 2007 - May 2010
Baxter BioScience January 2007 - June 2007
Baxter BioScience June 2006 - September 2006
Skills
Microsoft Office, Emerson DeltaV, Computer System..., Capital Projects, Change Control, Project Management, Equipment Commissioning, Lean Manufacturing, Validation, Operational Excellence, Automation, Process Engineering, Visio, Manufacturing, Engineering, CAPA
Education
University of California, Los Angeles 2002 — 2007
B.S., Chemical Engineering
Sequoia Consulting Group, LLC December 2014 - Present
Valspec September 2012 - November 2014
Baxter Bioscience May 2010 - August 2012
Baxter BioScience August 2007 - May 2010
Baxter BioScience January 2007 - June 2007
Baxter BioScience June 2006 - September 2006
Skills
Microsoft Office, Emerson DeltaV, Computer System..., Capital Projects, Change Control, Project Management, Equipment Commissioning, Lean Manufacturing, Validation, Operational Excellence, Automation, Process Engineering, Visio, Manufacturing, Engineering, CAPA
Education
University of California, Los Angeles 2002 — 2007
B.S., Chemical Engineering
Dorie Morgan Dorie Morgan's Valspec Experience September 2014 - Present
Job Documentation Specialist at VALSPEC
Industry Pharmaceuticals
Experience
VALSPEC September 2014 - Present
Lyophilization Technology, Inc. June 2008 - September 2014
Lyophilization Technology, Inc. March 2007 - May 2008
Starbucks Coffee Company July 2005 - January 2007
Skills
Sop, GMP, Training, Document Management, Pharmaceutical Industry, Microsoft Office, Management, Writing, Quality Assurance, PowerPoint, Clinical Trials, Blogging, Software Documentation, Microsoft Excel, Access, Microsoft Word, Public Speaking, SOP
Education
Muhlenberg College 2000 — 2005
B.A., Business Administration
VALSPEC September 2014 - Present
Lyophilization Technology, Inc. June 2008 - September 2014
Lyophilization Technology, Inc. March 2007 - May 2008
Starbucks Coffee Company July 2005 - January 2007
Skills
Sop, GMP, Training, Document Management, Pharmaceutical Industry, Microsoft Office, Management, Writing, Quality Assurance, PowerPoint, Clinical Trials, Blogging, Software Documentation, Microsoft Excel, Access, Microsoft Word, Public Speaking, SOP
Education
Muhlenberg College 2000 — 2005
B.A., Business Administration
Laura Brewer Laura Brewer's Valspec Experience August 2014 - Present
Job Manufacturing Engineer
Industry Industrial Automation
Experience
VALSPEC August 2014 - Present
Zenith Technologies January 2010 - December 2013
GlaxoSmithKline November 2008 - December 2009
GlaxoSmithKline October 2006 - October 2008
Skills
Commissioning, Automation, DCS, GMP, Testing, Change Control, DeltaV, Lean Manufacturing, Experion PKS, Honeywell DCS, TotalPlant Batch, Process Engineering, Computer System..., 21 CFR Part 11, Process Control, FDA, GAMP
Education
Lafayette College 2002 — 2006
B.S., Chemical Engineering
VALSPEC August 2014 - Present
Zenith Technologies January 2010 - December 2013
GlaxoSmithKline November 2008 - December 2009
GlaxoSmithKline October 2006 - October 2008
Skills
Commissioning, Automation, DCS, GMP, Testing, Change Control, DeltaV, Lean Manufacturing, Experion PKS, Honeywell DCS, TotalPlant Batch, Process Engineering, Computer System..., 21 CFR Part 11, Process Control, FDA, GAMP
Education
Lafayette College 2002 — 2006
B.S., Chemical Engineering
Janette Santana Janette Santana's Valspec Experience June 2012 - July 2013
Job MES Engineer at BristolMyers Squibb
Industry Industrial Automation
Experience
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
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
Sean Muldowney's Valspec Experience June 2012 - Present
Job Senior Validation Engineer at VALSPEC
Industry Industrial Automation
Experience
VALSPEC June 2012 - Present
VALSPEC June 2008 - June 2012
Nexans October 2007 - December 2007
Albemarle May 2005 - August 2005
Skills
Emerson DeltaV, Syncade, MES, Computer System..., Validation, Commissioning, GDP, GMP, Software Documentation, 21 CFR Part 11, Change Control, Automation, Process Control, Equipment Commissioning, Performance Testing, Pharmaceutical Industry
Education
Penn State University
Bachelor of Science (BS), Chemical Engineering
VALSPEC June 2012 - Present
VALSPEC June 2008 - June 2012
Nexans October 2007 - December 2007
Albemarle May 2005 - August 2005
Skills
Emerson DeltaV, Syncade, MES, Computer System..., Validation, Commissioning, GDP, GMP, Software Documentation, 21 CFR Part 11, Change Control, Automation, Process Control, Equipment Commissioning, Performance Testing, Pharmaceutical Industry
Education
Penn State University
Bachelor of Science (BS), Chemical Engineering
Cory Bowman's Valspec Experience February 2012 - Present
Job Engineering Supervisor at Valspec
Industry Biotechnology
Experience
Valspec February 2012 - Present
Valspec June 2004 - Present
Valspec January 2003 - June 2004
Proconex January 2002 - December 2002
ALSTOM Drives and Control May 2000 - September 2001
ALSTOM Drives and Controls June 1999 - May 2000
Skills
Instrumentation, Automation, Validation, Testing, Process Automation, Process Engineering, Manufacturing, Commissioning, Engineering, Software Documentation, Change Control, Quality System, WebDAV, Process Control, Quality Assurance, Pharmaceutical Industry, Project Management, GAMP, V&V, 21 CFR Part 11, Emerson DeltaV, Management, Sop, Control Logic, Continuous Improvement, Troubleshooting, Quality Management, Computer System...
Education
University of Pittsburgh 1994 — 1999
BS, Electrical Engineering
Valspec February 2012 - Present
Valspec June 2004 - Present
Valspec January 2003 - June 2004
Proconex January 2002 - December 2002
ALSTOM Drives and Control May 2000 - September 2001
ALSTOM Drives and Controls June 1999 - May 2000
Skills
Instrumentation, Automation, Validation, Testing, Process Automation, Process Engineering, Manufacturing, Commissioning, Engineering, Software Documentation, Change Control, Quality System, WebDAV, Process Control, Quality Assurance, Pharmaceutical Industry, Project Management, GAMP, V&V, 21 CFR Part 11, Emerson DeltaV, Management, Sop, Control Logic, Continuous Improvement, Troubleshooting, Quality Management, Computer System...
Education
University of Pittsburgh 1994 — 1999
BS, Electrical Engineering
Patrick Bowman Patrick Bowman's Valspec Experience January 2006 - March 2009
Job VicePresident of Marketing at Reliant Holdings, Inc
Industry Marketing and Advertising
Experience
Reliant Holdings, Inc July 2009 - Present
VALSPEC January 2006 - March 2009
Skills
Affiliate Marketing, Online Marketing, Co-registration, Lead Generation, Web Marketing, Email Marketing, Marketing, Online Advertising, Direct Marketing, SEO, Strategic Partnerships, Online Lead Generation
Education
Lebanon Valley College 1997 — 2002
BM, Music Recording Technology/Liberal Arts
Reliant Holdings, Inc July 2009 - Present
VALSPEC January 2006 - March 2009
Skills
Affiliate Marketing, Online Marketing, Co-registration, Lead Generation, Web Marketing, Email Marketing, Marketing, Online Advertising, Direct Marketing, SEO, Strategic Partnerships, Online Lead Generation
Education
Lebanon Valley College 1997 — 2002
BM, Music Recording Technology/Liberal Arts
Jonathan Schaeffer's Valspec Experience March 2002 - November 2006
Job Automation Engineer at AIV Solutions
Industry Industrial Automation
Experience
AIV Solutions November 2006 - Present
Valspec March 2002 - November 2006
Skills
Emerson DeltaV, ABB 800xA
Education
Clarkson University 1997 — 2001
BS, Chemical Engineering
AIV Solutions November 2006 - Present
Valspec March 2002 - November 2006
Skills
Emerson DeltaV, ABB 800xA
Education
Clarkson University 1997 — 2001
BS, Chemical Engineering
Iqbal Sheikh Iqbal Sheikh's Valspec Experience 2001 - 2004
Job CSV Quality & Compliance at Merck
Industry Performing Arts
Experience
Merck Pharmaceuticals November 2009 - Present
Schering-Plough Corporation 2001 - November 2009
Valspec 2001 - 2004
Jade Corporation 1994 - 2001
G&W 1987 - 1993
Soofer Company, Tehran July 1975 - January 1979
Skills
CQA (Certified Quality..., ASQ (American Society..., Project Management, Steven's Institute, NJ, Understanding &..., ISA Training Institute...., DeltaV Operate..., Fischer-Rosemont –..., 21 CFR Part 11, GxP, CQA, ASQ, GAMP, Computer System..., Change Control, Validation, Institute, Applying, SDLC
Education
Pennsylvania State University-Great Valley Graduate Center 1981 — 1983
Masters, Industrial Engineering
University of Engineering and Technology, Lahore 1969 — 1973
Electrical Engineering, Electronics & Communications
Merck Pharmaceuticals November 2009 - Present
Schering-Plough Corporation 2001 - November 2009
Valspec 2001 - 2004
Jade Corporation 1994 - 2001
G&W 1987 - 1993
Soofer Company, Tehran July 1975 - January 1979
Skills
CQA (Certified Quality..., ASQ (American Society..., Project Management, Steven's Institute, NJ, Understanding &..., ISA Training Institute...., DeltaV Operate..., Fischer-Rosemont –..., 21 CFR Part 11, GxP, CQA, ASQ, GAMP, Computer System..., Change Control, Validation, Institute, Applying, SDLC
Education
Pennsylvania State University-Great Valley Graduate Center 1981 — 1983
Masters, Industrial Engineering
University of Engineering and Technology, Lahore 1969 — 1973
Electrical Engineering, Electronics & Communications
Nelson Zhou Nelson Zhou's Valspec Experience August 2014 - Present
Job MES Validation Engineer at VALSPEC
Industry Chemicals
Experience
VALSPEC August 2014 - Present
PSC Biotech June 2012 - January 2014
Skills
Laboratory, Validation, GMP, CAPA, FDA, Sop, Computer System...
Education
Rutgers, The State University of New Jersey-New Brunswick 2010 — 2014
Bachelor of Science (B.S.), Chemical Engineering
VALSPEC August 2014 - Present
PSC Biotech June 2012 - January 2014
Skills
Laboratory, Validation, GMP, CAPA, FDA, Sop, Computer System...
Education
Rutgers, The State University of New Jersey-New Brunswick 2010 — 2014
Bachelor of Science (B.S.), Chemical Engineering
Michael Zandy Michael Zandy's Valspec Experience June 2015 - Present
Job Lead Validation Engineer at VALSPEC
Industry Pharmaceuticals
Experience
VALSPEC June 2015 - Present
Valspec March 2013 - June 2015
RoviSys July 2012 - March 2013
RoviSys June 2012 - March 2013
RoviSys December 2011 - June 2012
RoviSys May 2007 - December 2011
Education
Cleveland State University 2010 — 2011
Master of Science (MS), Electrical Egnineering
Cleveland State University 2004 — 2010
Bachelor of Science (BS), Electrical and Electronics Engineering
University of Newcastle 2006 — 2006
VALSPEC June 2015 - Present
Valspec March 2013 - June 2015
RoviSys July 2012 - March 2013
RoviSys June 2012 - March 2013
RoviSys December 2011 - June 2012
RoviSys May 2007 - December 2011
Education
Cleveland State University 2010 — 2011
Master of Science (MS), Electrical Egnineering
Cleveland State University 2004 — 2010
Bachelor of Science (BS), Electrical and Electronics Engineering
University of Newcastle 2006 — 2006
Isabel Rodriguez, PE's Valspec Experience March 2013 - December 2013
Job Owner and Principal Engineer IRP Consulting Integrated Regulatory Compliance and Project Management
Industry Biotechnology
Experience
IRP Consulting January 2010 - Present
Sanofi February 2014 - March 2015
VALSPEC March 2013 - December 2013
Hyde Engineering + Consulting September 2011 - August 2012
Valspec February 2010 - August 2011
ENGINEERED ENERGY SOLUTIONS January 2009 - December 2009
Brock Solutions 2007 - 2008
Global Automation Partners 2005 - 2007
Eli Lilly 2003 - 2007
Coneco de Puerto Rico 2004 - 2005
Skills
Computer System..., Automation, Pharmaceutical Industry, GAMP, 21 CFR Part 11, Validation, Change Control, GMP, Lifesciences, Biotechnology, Project Management, FDA, GxP, Instrumentation, V&V, Technology Transfer, Process Automation, Commissioning, Biopharmaceuticals, CAPA, MES, Process Simulation, Sop, LIMS, Medical Devices, DCS, Process Engineering
Education
Harvard University, Harvard Extension School 2014 — 2016
Graduate Certificate, Strategic Management
University of Puerto Rico 1997 — 2001
BSEE, Electrical Engineering - Controls
IRP Consulting January 2010 - Present
Sanofi February 2014 - March 2015
VALSPEC March 2013 - December 2013
Hyde Engineering + Consulting September 2011 - August 2012
Valspec February 2010 - August 2011
ENGINEERED ENERGY SOLUTIONS January 2009 - December 2009
Brock Solutions 2007 - 2008
Global Automation Partners 2005 - 2007
Eli Lilly 2003 - 2007
Coneco de Puerto Rico 2004 - 2005
Skills
Computer System..., Automation, Pharmaceutical Industry, GAMP, 21 CFR Part 11, Validation, Change Control, GMP, Lifesciences, Biotechnology, Project Management, FDA, GxP, Instrumentation, V&V, Technology Transfer, Process Automation, Commissioning, Biopharmaceuticals, CAPA, MES, Process Simulation, Sop, LIMS, Medical Devices, DCS, Process Engineering
Education
Harvard University, Harvard Extension School 2014 — 2016
Graduate Certificate, Strategic Management
University of Puerto Rico 1997 — 2001
BSEE, Electrical Engineering - Controls
Steve Slupe's Valspec Experience July 2015 - Present
Job Business Development Manager at VALSPEC
Industry Information Technology and Services
Experience
VALSPEC July 2015 - Present
ACS Group (American CyberSystems) March 2014 - June 2015
SESC January 2012 - February 2014
TEKsystems April 1994 - December 2011
Education
La Salle University
VALSPEC July 2015 - Present
ACS Group (American CyberSystems) March 2014 - June 2015
SESC January 2012 - February 2014
TEKsystems April 1994 - December 2011
Education
La Salle University
Kelly Barletta's Valspec Experience 2004 - 2007
Job Student at Saint Joseph's University
Industry Education Management
Experience
valspec 2004 - 2007
Education
Saint Joseph's University 2004 — 2007
valspec 2004 - 2007
Education
Saint Joseph's University 2004 — 2007
Courtney Walker's Valspec Experience 2002 - 2005
Job Project Manager at GlaxoSmithKline
Industry Pharmaceuticals
Experience
GlaxoSmithKline 2007 - Present
Neotropix June 2006 - June 2007
Valspec/Proconex 2002 - 2005
VALSPEC 2002 - 2005
Rhone-Poulenc Rorer 1998 - 1999
Skills
Computer System..., Validation, GMP, Pharmaceutical Industry, CAPA
Education
Penn State University 1997 — 2001
B.S., Biology & Psychology
GlaxoSmithKline 2007 - Present
Neotropix June 2006 - June 2007
Valspec/Proconex 2002 - 2005
VALSPEC 2002 - 2005
Rhone-Poulenc Rorer 1998 - 1999
Skills
Computer System..., Validation, GMP, Pharmaceutical Industry, CAPA
Education
Penn State University 1997 — 2001
B.S., Biology & Psychology
Curt Gendler's Valspec Experience July 2014 - August 2014
Job Senior Compliance Specialist R&D CSV at Innovative Pharma Solutions, Inc.
Industry Medical Devices
Experience
Innovative Pharma Solutions, Inc. June 2015 - Present
VALSPEC July 2014 - August 2014
Alcon Research, Ltd March 2004 - July 2014
CimQuest 2001 - 2004
B&G Manufacturing May 1999 - March 2001
Oki Data Americas January 1997 - September 1998
MircoAge of Exton 1996 - 1996
Premier Solutions Ltd. 1994 - 1996
Rabbit Software 1993 - 1994
Skills
Pharmaceutics, FDA, 21 CFR Part 11, Pharmaceutical Industry, Change Control, Quality Assurance, SDLC, Software Documentation, GMP, Quality System, Computer System..., Process Improvement, Testing, Medical Devices, Manufacturing, PMP, CAPA, GAMP, Sop, Management, Software Development, ISO 13485, Quality Management, Leadership, Enterprise Software, Analysis, Microsoft SQL Server, Data Management, Integration, Visio, Software Quality..., Information Technology, Technical Writing, SPC, Document Management, Quality Auditing, Unix, Regulatory Affairs, GxP, Six Sigma, GCP, V&V, Validation, Process Simulation, Cross-functional Team..., Project Management, SOP
Education
Colorado Technical University 2009 — 2011
BS, Information Technology, Summa Cum Laude
Community College of Philadelphia 1977 — 1979
Associate of Science, Chemistry
Northeast High 1972 — 1975
Innovative Pharma Solutions, Inc. June 2015 - Present
VALSPEC July 2014 - August 2014
Alcon Research, Ltd March 2004 - July 2014
CimQuest 2001 - 2004
B&G Manufacturing May 1999 - March 2001
Oki Data Americas January 1997 - September 1998
MircoAge of Exton 1996 - 1996
Premier Solutions Ltd. 1994 - 1996
Rabbit Software 1993 - 1994
Skills
Pharmaceutics, FDA, 21 CFR Part 11, Pharmaceutical Industry, Change Control, Quality Assurance, SDLC, Software Documentation, GMP, Quality System, Computer System..., Process Improvement, Testing, Medical Devices, Manufacturing, PMP, CAPA, GAMP, Sop, Management, Software Development, ISO 13485, Quality Management, Leadership, Enterprise Software, Analysis, Microsoft SQL Server, Data Management, Integration, Visio, Software Quality..., Information Technology, Technical Writing, SPC, Document Management, Quality Auditing, Unix, Regulatory Affairs, GxP, Six Sigma, GCP, V&V, Validation, Process Simulation, Cross-functional Team..., Project Management, SOP
Education
Colorado Technical University 2009 — 2011
BS, Information Technology, Summa Cum Laude
Community College of Philadelphia 1977 — 1979
Associate of Science, Chemistry
Northeast High 1972 — 1975
Teddy Bowman Jr's Valspec Experience April 2010 - November 2010
Job Quality Specialist 2
Industry Pharmaceuticals
Experience
Phlexglobal June 2013 - Present
Phlexglobal May 2011 - May 2013
Valspec April 2010 - November 2010
AstraZeneca November 2008 - June 2010
ALMAC Clinical Services July 2008 - October 2008
ALMAC Clinical Services January 2008 - July 2008
Centocor November 2006 - January 2008
Centocor 2004 - 2007
Orthovita Inc April 2002 - October 2004
Skills
GMP, Software Documentation, Validation, Change Control, Training, Biotechnology, CRO, Clinical Trials, GCP, Project Management, SOP, FDA
Education
Immaculata University 2005 — 2008
BA, Organization Dynamics
CHI Institute
Certification, Surgical Technology
Phlexglobal June 2013 - Present
Phlexglobal May 2011 - May 2013
Valspec April 2010 - November 2010
AstraZeneca November 2008 - June 2010
ALMAC Clinical Services July 2008 - October 2008
ALMAC Clinical Services January 2008 - July 2008
Centocor November 2006 - January 2008
Centocor 2004 - 2007
Orthovita Inc April 2002 - October 2004
Skills
GMP, Software Documentation, Validation, Change Control, Training, Biotechnology, CRO, Clinical Trials, GCP, Project Management, SOP, FDA
Education
Immaculata University 2005 — 2008
BA, Organization Dynamics
CHI Institute
Certification, Surgical Technology
Scott Zeanchock's Valspec Experience 2002 - 2008
Job Validation Engineer at Janssen (A Johnson & Johnson Company)
Industry Pharmaceuticals
Experience
Centocor 2008 - Present
Valspec 2002 - 2008
Skills
CAPA, FDA, Validation, GMP
Education
Penn State University 1997 — 2002
Biology
Centocor 2008 - Present
Valspec 2002 - 2008
Skills
CAPA, FDA, Validation, GMP
Education
Penn State University 1997 — 2002
Biology
Bob Pike's Valspec Experience 2008 - 2010
Job Validation Lead at Hospira
Industry Pharmaceuticals
Experience
Hospira August 2013 - Present
Novartis September 2012 - Present
Genzyme January 2012 - September 2012
Stryker Medical Devices December 2010 - April 2011
St. Jude Medical March 2010 - November 2010
Fluor 2009 - April 2010
Novartis October 2009 - March 2010
Valspec 2008 - 2010
MedImmune March 2009 - November 2009
sanoft pasteur September 2007 - April 2009
Skills
Change Control, FDA, 21 CFR Part 11, Testing, Validation, Computer System..., GxP, Medical Devices, Laboratory Equipment, CSV, FMEA
Education
Temple University 1970 — 1974
BSEE, Electrical and Electronics Engineering
Temple University 1970 — 1974
BSEE, Electrical Engineering
Hospira August 2013 - Present
Novartis September 2012 - Present
Genzyme January 2012 - September 2012
Stryker Medical Devices December 2010 - April 2011
St. Jude Medical March 2010 - November 2010
Fluor 2009 - April 2010
Novartis October 2009 - March 2010
Valspec 2008 - 2010
MedImmune March 2009 - November 2009
sanoft pasteur September 2007 - April 2009
Skills
Change Control, FDA, 21 CFR Part 11, Testing, Validation, Computer System..., GxP, Medical Devices, Laboratory Equipment, CSV, FMEA
Education
Temple University 1970 — 1974
BSEE, Electrical and Electronics Engineering
Temple University 1970 — 1974
BSEE, Electrical Engineering
Scott Runkle's Valspec Experience January 2002 - June 2007
Job QA Specialist at GlaxoSmithKline
Industry Biotechnology
Experience
GlaxoSmithKline January 2015 - Present
GlaxoSmithKline March 2010 - January 2015
GlaxoSmithKline June 2007 - February 2010
VALSPEC January 2002 - June 2007
Skills
Validation, Cleaning Validation, Process Validation, Computer System..., Biopharmaceuticals, Equipment Qualification, Quality Auditing, Quality System, Technology Transfer, HPLC, Change Control, V&V, Regulatory Affairs, Sterilization, CAPA, 21 CFR Part 11, Sop, GLP, GAMP, Pharmaceutical Industry, ISO 13485, LIMS, Quality Control, GMP, FDA, Trackwise, Quality Assurance, Aseptic Processing, Biotechnology, Regulatory Requirements, Medical Devices, GxP, Process Simulation, Analytical Chemistry, SOP, TrackWise
Education
The Pennsylvania State University
Bachelor of Science, Aerospace Engineering
GlaxoSmithKline January 2015 - Present
GlaxoSmithKline March 2010 - January 2015
GlaxoSmithKline June 2007 - February 2010
VALSPEC January 2002 - June 2007
Skills
Validation, Cleaning Validation, Process Validation, Computer System..., Biopharmaceuticals, Equipment Qualification, Quality Auditing, Quality System, Technology Transfer, HPLC, Change Control, V&V, Regulatory Affairs, Sterilization, CAPA, 21 CFR Part 11, Sop, GLP, GAMP, Pharmaceutical Industry, ISO 13485, LIMS, Quality Control, GMP, FDA, Trackwise, Quality Assurance, Aseptic Processing, Biotechnology, Regulatory Requirements, Medical Devices, GxP, Process Simulation, Analytical Chemistry, SOP, TrackWise
Education
The Pennsylvania State University
Bachelor of Science, Aerospace Engineering
Julia Balliet's Valspec Experience September 2004 - August 2006
Job Quality/CAPA Consultant
Industry Pharmaceuticals
Experience
Validant August 2015 - Present
Validant November 2014 - July 2015
Validant January 2012 - October 2014
Radiopharmaceuticals Company June 2006 - September 2011
Valspec September 2004 - August 2006
Emerson July 2002 - July 2003
Monsanto November 1997 - January 2000
Monsanto November 1993 - November 1997
Monsanto November 1992 - November 1993
Monsanto July 1980 - October 1992
Skills
GMP, SAP, CAPA, Sop, Quality System, Quality Assurance, Pharmaceutical Industry, Change Control, FDA, Quality Control, Root Cause Analysis, Computer System..., Biopharmaceuticals, Validation, 21 CFR Part 11, Lifesciences, GxP, V, LIMS, Life Sciences, SOP
Education
Lindenwood University
MBA
University of Wisconsin-Madison
BS
Validant August 2015 - Present
Validant November 2014 - July 2015
Validant January 2012 - October 2014
Radiopharmaceuticals Company June 2006 - September 2011
Valspec September 2004 - August 2006
Emerson July 2002 - July 2003
Monsanto November 1997 - January 2000
Monsanto November 1993 - November 1997
Monsanto November 1992 - November 1993
Monsanto July 1980 - October 1992
Skills
GMP, SAP, CAPA, Sop, Quality System, Quality Assurance, Pharmaceutical Industry, Change Control, FDA, Quality Control, Root Cause Analysis, Computer System..., Biopharmaceuticals, Validation, 21 CFR Part 11, Lifesciences, GxP, V, LIMS, Life Sciences, SOP
Education
Lindenwood University
MBA
University of Wisconsin-Madison
BS
Jamie Darragh's Valspec Experience February 2015 - March 2015
Job Turn Over Package Coordinator at Valspec
Industry Biotechnology
Experience
Valspec February 2015 - March 2015
Genzyme November 2012 - October 2013
Biogen Idec August 2011 - June 2012
Lonza 2011 - 2011
Sepracor January 2007 - February 2009
AEROTEK SCIENTIFIC LLC June 2007 - October 2007
AEROTEK SCIENTIFIC LLC November 2006 - June 2007
Osmetech Molecular Diagnostics 2006 - 2007
SeraCare Life Sciences May 2005 - October 2006
Per Diem March 2002 - April 2005
Skills
GMP, Biotechnology, Sop, Validation, HPLC, CAPA, Manufacturing, Quality Assurance, Sourcing, SOP, Training, Management, Applicant Tracking..., Quality Control, Pharmaceutical Industry, Microsoft Office, R&D, Leadership, FDA, Project Management
Education
Apollo College 2000 — 2002
Pharamacy
UNITED STATES AIR FORCE
EAST BRIDGEWATER HIGH SCHOOL EAST
General
Bridgewater State University
BS, Chemistry
Valspec February 2015 - March 2015
Genzyme November 2012 - October 2013
Biogen Idec August 2011 - June 2012
Lonza 2011 - 2011
Sepracor January 2007 - February 2009
AEROTEK SCIENTIFIC LLC June 2007 - October 2007
AEROTEK SCIENTIFIC LLC November 2006 - June 2007
Osmetech Molecular Diagnostics 2006 - 2007
SeraCare Life Sciences May 2005 - October 2006
Per Diem March 2002 - April 2005
Skills
GMP, Biotechnology, Sop, Validation, HPLC, CAPA, Manufacturing, Quality Assurance, Sourcing, SOP, Training, Management, Applicant Tracking..., Quality Control, Pharmaceutical Industry, Microsoft Office, R&D, Leadership, FDA, Project Management
Education
Apollo College 2000 — 2002
Pharamacy
UNITED STATES AIR FORCE
EAST BRIDGEWATER HIGH SCHOOL EAST
General
Bridgewater State University
BS, Chemistry
Owen Campney's Valspec Experience July 2011 - February 2012
Job Control Systems Engineer at NER
Industry Industrial Automation
Experience
Zentek August 2012 - November 2012
Central Texas Discover Engineering May 2012 - May 2012
Williamson County May 2012 - May 2012
Valspec July 2011 - February 2012
Hi-Tech Focused Forum of 50Plus Job Club July 2010 - November 2011
Merck Sharp & Dohme January 2010 - May 2010
Hi-Tech Focused Forum of 50Plus Job club October 2009 - January 2010
BJM Job club 2009 - 2010
Emerson Process Management March 2005 - May 2009
Cornerstone Automation Systems Inc. 2003 - 2004
Skills
Steam Turbines, Control System Design, Process Control, Advanced Process Control, Dynamic Simulation, Energy Issues, Instrument Control, Control Systems Design, Electrical Engineering, DCS, Energy, Electronics, Process Automation, PLC, Engineering, Automation, Instrumentation, HMIs
Education
Washington University in St. Louis 1979 — 1979
cert.
Iowa State University 1971 — 1975
BS
Zentek August 2012 - November 2012
Central Texas Discover Engineering May 2012 - May 2012
Williamson County May 2012 - May 2012
Valspec July 2011 - February 2012
Hi-Tech Focused Forum of 50Plus Job Club July 2010 - November 2011
Merck Sharp & Dohme January 2010 - May 2010
Hi-Tech Focused Forum of 50Plus Job club October 2009 - January 2010
BJM Job club 2009 - 2010
Emerson Process Management March 2005 - May 2009
Cornerstone Automation Systems Inc. 2003 - 2004
Skills
Steam Turbines, Control System Design, Process Control, Advanced Process Control, Dynamic Simulation, Energy Issues, Instrument Control, Control Systems Design, Electrical Engineering, DCS, Energy, Electronics, Process Automation, PLC, Engineering, Automation, Instrumentation, HMIs
Education
Washington University in St. Louis 1979 — 1979
cert.
Iowa State University 1971 — 1975
BS
Issella Iglesias's Valspec Experience May 2008 - September 2008
Job Project Manager at Groupe Conseil Silva Inc.
Industry Biotechnology
Experience
Groupe Conseil Silva Inc. May 2012 - Present
Validapro Biosciences October 2008 - July 2009
Valspec May 2008 - September 2008
Esteves Consulting Services (ECS) January 2007 - May 2008
Washington Engineers formerly Washington Groupn Internationl October 2003 - January 2007
Skills
Validation, FDA, Sop, Testing, Software Documentation, Manufacturing, Automation, PLC, Troubleshooting, GMP, Process Control, Quality System
Education
McGill University 2013 — 2013
Continuing Education, Project Management
Recinto Universitario de Mayaguez 1987 — 1993
Bachelor of Science, Electrical Engineer Major in Power
Groupe Conseil Silva Inc. May 2012 - Present
Validapro Biosciences October 2008 - July 2009
Valspec May 2008 - September 2008
Esteves Consulting Services (ECS) January 2007 - May 2008
Washington Engineers formerly Washington Groupn Internationl October 2003 - January 2007
Skills
Validation, FDA, Sop, Testing, Software Documentation, Manufacturing, Automation, PLC, Troubleshooting, GMP, Process Control, Quality System
Education
McGill University 2013 — 2013
Continuing Education, Project Management
Recinto Universitario de Mayaguez 1987 — 1993
Bachelor of Science, Electrical Engineer Major in Power
Dawn Ruggiero's Valspec Experience January 2014 - Present
Job Vice President at VALSPEC
Industry Biotechnology
Experience
VALSPEC January 2014 - Present
Valspec June 2002 - December 2013
PROCONEX June 2000 - June 2002
PROCONEX December 1997 - June 2000
Bristol-Myers Squibb May 1993 - December 1997
Skills
Computer Systems..., Manufacturing Execution..., MES, V&V, Computer System..., Validation, Change Control, Commissioning, GAMP, Process Engineering, Process Control, Process Automation, GMP, 21 CFR Part 11, DCS, Biopharmaceuticals, FDA, PLC, Instrumentation, Automation, Process Automation,...
Education
Rensselaer Polytechnic Institute 1989 — 1993
BS
VALSPEC January 2014 - Present
Valspec June 2002 - December 2013
PROCONEX June 2000 - June 2002
PROCONEX December 1997 - June 2000
Bristol-Myers Squibb May 1993 - December 1997
Skills
Computer Systems..., Manufacturing Execution..., MES, V&V, Computer System..., Validation, Change Control, Commissioning, GAMP, Process Engineering, Process Control, Process Automation, GMP, 21 CFR Part 11, DCS, Biopharmaceuticals, FDA, PLC, Instrumentation, Automation, Process Automation,...
Education
Rensselaer Polytechnic Institute 1989 — 1993
BS
Bill Meier's Valspec Experience January 2006 - June 2007
Job Sr Program Manager at LexisNexis, Health Market Science
Industry
Experience
Health Market Science April 2013 - Present
CSC July 2007 - March 2013
Valspec January 2006 - June 2007
First Consulting Group June 2000 - December 2005
Education
Rensselaer Polytechnic Institute at Hartford 1983 — 1987
MS, Operations Management
University of Wisconsin-Madison 1978 — 1982
BS, Industrial Engineering
Health Market Science April 2013 - Present
CSC July 2007 - March 2013
Valspec January 2006 - June 2007
First Consulting Group June 2000 - December 2005
Education
Rensselaer Polytechnic Institute at Hartford 1983 — 1987
MS, Operations Management
University of Wisconsin-Madison 1978 — 1982
BS, Industrial Engineering
Erica Clay's Valspec Experience June 2007 - October 2011
Job Systems Engineer at Proconex
Industry Pharmaceuticals
Experience
Proconex October 2011 - Present
VALSPEC June 2007 - October 2011
Pactiv, LLC May 2006 - August 2006
Skills
DeltaV, Computer System..., Validation, Process Control, GMP, GAMP, WebDAV, Change Control, Sop, Process Automation, V&V, CAPA, FDA, DCS, Quality Assurance, 21 CFR Part 11
Education
Villanova University 2008 — 2011
MS, Chemical Engineering
Penn State University 2002 — 2007
BS, Chemical Engineering
Proconex October 2011 - Present
VALSPEC June 2007 - October 2011
Pactiv, LLC May 2006 - August 2006
Skills
DeltaV, Computer System..., Validation, Process Control, GMP, GAMP, WebDAV, Change Control, Sop, Process Automation, V&V, CAPA, FDA, DCS, Quality Assurance, 21 CFR Part 11
Education
Villanova University 2008 — 2011
MS, Chemical Engineering
Penn State University 2002 — 2007
BS, Chemical Engineering
Jaycee Hofbauer's Valspec Experience April 2001 - February 2014
Job Associate Director, Computer System Compliance at Merck
Industry Industrial Automation
Experience
Merck & Co February 2014 - Present
Valspec April 2001 - February 2014
Skills
Change Control, 21 CFR Part 11, Automation, Computer System..., Validation, GMP, GAMP, MES, CAPA, Process Control, Cleaning Validation, FDA, GxP, Quality System
Education
Penn State University 1991 — 1996
BS, Mechanical Engineering
Merck & Co February 2014 - Present
Valspec April 2001 - February 2014
Skills
Change Control, 21 CFR Part 11, Automation, Computer System..., Validation, GMP, GAMP, MES, CAPA, Process Control, Cleaning Validation, FDA, GxP, Quality System
Education
Penn State University 1991 — 1996
BS, Mechanical Engineering
Kevin Kasper's Valspec Experience June 2000 - Present
Job Lead / Sr Validation Engineer at Valspec
Industry Industrial Automation
Experience
Merck 2009 - Present
Valspec June 2000 - Present
GSK 2010 - 2010
Skills
Computer System..., Validation, 21 CFR Part 11, GMP, GAMP, CAPA, Change Control, V&V, Automation, FDA, Pharmaceutical Industry, SOP, Biotechnology, Quality System, Quality Assurance, GxP, Biopharmaceuticals, Manufacturing, Process Engineering
Education
Penn State University 1995 — 2000
Bachelor of Science (B.S.), Chemical Engineering
Merck 2009 - Present
Valspec June 2000 - Present
GSK 2010 - 2010
Skills
Computer System..., Validation, 21 CFR Part 11, GMP, GAMP, CAPA, Change Control, V&V, Automation, FDA, Pharmaceutical Industry, SOP, Biotechnology, Quality System, Quality Assurance, GxP, Biopharmaceuticals, Manufacturing, Process Engineering
Education
Penn State University 1995 — 2000
Bachelor of Science (B.S.), Chemical Engineering
Lora Zeanchock's Valspec Experience 2004 - 2006
Job Process Engineer at Jacobs Engineering Group
Industry Pharmaceuticals
Experience
Jacobs Engineering June 2012 - Present
Castle Hill Technologies August 2010 - May 2012
Jacobs Engineering August 2006 - August 2010
Valspec 2004 - 2006
Skills
Chemical Engineering, Commissioning, HAZOP, P, Process Engineering, Process Simulation
Education
Penn State University 2000 — 2004
ChE, Chemical Engineering
Jacobs Engineering June 2012 - Present
Castle Hill Technologies August 2010 - May 2012
Jacobs Engineering August 2006 - August 2010
Valspec 2004 - 2006
Skills
Chemical Engineering, Commissioning, HAZOP, P, Process Engineering, Process Simulation
Education
Penn State University 2000 — 2004
ChE, Chemical Engineering
Peter Howe's Valspec Experience August 2012 - November 2012
Job Web Developer at CleanAlert LLC
Industry Computer Software
Experience
CleanAlert LLC March 2014 - Present
Comprehensive Auto Resources Company October 2013 - December 2013
Artech Information Systems January 2013 - August 2013
Valspec August 2012 - November 2012
Technisource March 2012 - June 2012
SGT Automated Framing Consultants, LLC September 2011 - November 2011
Wood Tech Systems LLC March 2011 - April 2011
Maronda Homes August 2006 - October 2010
Bentley Systems 1993 - 2004
Villanova University 1999 - 2003
Skills
C, Java, Databases, Programming, Software Development, PL/SQL, SQL, HTML, Customer Relations, Customer Service, Software Engineering, Access, Visual Studio, Visual Basic, Oracle, JavaScript, WordPress, Microsoft Office, Windows, XML, Microstation, Software Design, Architecture, Unix, Troubleshooting, Microsoft SQL Server, C++, C#, Operating Systems, Requirements Analysis, .NET, Object Oriented Design, Integration, Software Project..., Software Documentation, Architectures
Education
Drexel University 1986 — 1989
MS, Computer Science
Millersville University of Pennsylvania 1977 — 1982
BS, Computer Science
CleanAlert LLC March 2014 - Present
Comprehensive Auto Resources Company October 2013 - December 2013
Artech Information Systems January 2013 - August 2013
Valspec August 2012 - November 2012
Technisource March 2012 - June 2012
SGT Automated Framing Consultants, LLC September 2011 - November 2011
Wood Tech Systems LLC March 2011 - April 2011
Maronda Homes August 2006 - October 2010
Bentley Systems 1993 - 2004
Villanova University 1999 - 2003
Skills
C, Java, Databases, Programming, Software Development, PL/SQL, SQL, HTML, Customer Relations, Customer Service, Software Engineering, Access, Visual Studio, Visual Basic, Oracle, JavaScript, WordPress, Microsoft Office, Windows, XML, Microstation, Software Design, Architecture, Unix, Troubleshooting, Microsoft SQL Server, C++, C#, Operating Systems, Requirements Analysis, .NET, Object Oriented Design, Integration, Software Project..., Software Documentation, Architectures
Education
Drexel University 1986 — 1989
MS, Computer Science
Millersville University of Pennsylvania 1977 — 1982
BS, Computer Science
Jessica Cornett's Valspec Experience May 2008 - April 2011
Job Clinical Laboratory Client Services/Marketing Representative
Industry Hospital & Health Care
Experience
Our Lady of Bellefonte Hospital July 2011 - Present
Valspec May 2008 - April 2011
Reading Area Community College January 2008 - April 2011
Skills
Quality Assurance, Biotechnology, Pharmaceutical Industry, Quality Control, Stability Studies, Medical Technology, Laboratory Medicine, Marketing, Project Management
Education
Shawnee State University
Our Lady of Bellefonte Hospital July 2011 - Present
Valspec May 2008 - April 2011
Reading Area Community College January 2008 - April 2011
Skills
Quality Assurance, Biotechnology, Pharmaceutical Industry, Quality Control, Stability Studies, Medical Technology, Laboratory Medicine, Marketing, Project Management
Education
Shawnee State University
Donna (Conway) Washington's Valspec Experience June 2008 - Present
Job Senior Validation Engineer at Valspec
Industry Industrial Automation
Experience
VALSPEC June 2008 - Present
Skills
DeltaV, 21 CFR Part 11, Process Validation, Change Control, Validation, GMP, CAPA, FDA, Automation, GxP, Documentation, Technical Writing, DCS, SOP, GAMP, Word, Excel, Computer System..., WebDAV, Process Control, Software Documentation, Commissioning, Biotechnology
Education
Keller Graduate School of Management of DeVry University 2011 — 2014
Master's Degree, Project Management
Penn State University 2004 — 2008
BS, Chemical Engineering
VALSPEC June 2008 - Present
Skills
DeltaV, 21 CFR Part 11, Process Validation, Change Control, Validation, GMP, CAPA, FDA, Automation, GxP, Documentation, Technical Writing, DCS, SOP, GAMP, Word, Excel, Computer System..., WebDAV, Process Control, Software Documentation, Commissioning, Biotechnology
Education
Keller Graduate School of Management of DeVry University 2011 — 2014
Master's Degree, Project Management
Penn State University 2004 — 2008
BS, Chemical Engineering
Nimit Amipara's Valspec Experience January 2015 - Present
Job Lead Validation Engineer (Automation CQV Lead) at Valspec
Industry Biotechnology
Experience
VALSPEC January 2015 - Present
Valspec February 2012 - January 2015
Valspec February 2009 - February 2012
Valspec January 2007 - February 2009
Valspec (PROCONEX) June 2007 - December 2007
Skills
Validation, Biopharmaceuticals, Computer System..., GAMP, 21 CFR Part 11, Cleaning Validation, Quality Control, Automation, Change Control, Delta V, DCS, GxP, CAPA, V&V, GMP, Quality System, Trackwise, Quality by Design, Access, Syncade, ASTM E2500, Macros, TOP, Cost estimation, Project Schedule, Macro, ASTM, Project Estimation
Education
Stevens Institute of Technology 2004 — 2005
Masters of Engineering, Chemical Engineering
Anuradha Engineering College 1999 — 2003
Bachelor's degree, Chemical Engineering
VALSPEC January 2015 - Present
Valspec February 2012 - January 2015
Valspec February 2009 - February 2012
Valspec January 2007 - February 2009
Valspec (PROCONEX) June 2007 - December 2007
Skills
Validation, Biopharmaceuticals, Computer System..., GAMP, 21 CFR Part 11, Cleaning Validation, Quality Control, Automation, Change Control, Delta V, DCS, GxP, CAPA, V&V, GMP, Quality System, Trackwise, Quality by Design, Access, Syncade, ASTM E2500, Macros, TOP, Cost estimation, Project Schedule, Macro, ASTM, Project Estimation
Education
Stevens Institute of Technology 2004 — 2005
Masters of Engineering, Chemical Engineering
Anuradha Engineering College 1999 — 2003
Bachelor's degree, Chemical Engineering