Robb Kavanagh

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MES Engineer

Barrington, NJ

Name: robb Kavanagh
Phone: 215.740.1310
Email: mailto:robbkavanagh@hotmail.com
Home Location: US-NJ-Barrington-08007 (US Citizen)

Will Relocate To:

Experience
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Most Recent Title: Global Program Manager
Experience: 20 Years
Most Recent Pay: 115.00 USD per hour
Managed Others: Yes (150 others)
Spoken languages: English, Dutch, French, Spanish
Sec. Clearance: No
Certifications: ASQ-6 Sigma
PMI
FDA audits
Inspection Training
GMP
GLP
GCP
APICS
SDLC – Computer Validation
GAMP
MES
ISPE
Clinical Trials Supply Chain Part 11
Wharton Business Plan Development
VB
AutoCAD
MS-Access
NT Server
PLC Prog

Company Information

Education
=================================================================
Not Provided

Desired Position
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Job Type: Full-Time
Desired Pay: 140,000 USD per year
Max Commute: 50 miles
Travel Preference: Up to 25%

Interests
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Biotech (1 Year experience)
Consultant (10 Years experience)
Information Technology (20 Years experience)
Pharmaceutical (10 Years experience)
Professional Services (10 Years experience)

Resume
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Objective – A Director/ Sr.Program-Project Manager / Sr. Consultant
position preferably in the global regulated industry that I can use my
skill-set and experience to lead projects to remediate, improve or
implement quality technology systems and processes. Willing to travel
up to 100% of the time, including nationally and internationally –
prefer EU, Western Europe, Caribbean, or Singapore, Pacific-Rim –Asia
Pacific

Summary – 20 plus years of hardware & software development,
implementation, consulting and Business Development, with extensive
client contact experience in leading edge technologies through
extensive national and international travel. Strengths include strong
technical and people skills, mediator between operations and technical
organizations, development of methodologies and documentation
standards, proposal development, project management, hands on knowledge
of system SDLC- Software Development Life Cycle and validation for the
regulated Industry including cGMP and GAMP, extensive experience with
EBR-Electronic Batch Records and Lot genealogy requirements,
understanding of batch, continuous batch, extrusion manufacturing
processes and typical manufacturing operations for regulated and non
regulated industries, business marketing and presentation skills,
change management, as well as training skills. Experience includes
budgeting, staff management and development, business development.
Technical background includes electronics hardware development,
software development, network infrastructure design, implementation,
systems integration, technology evaluation, custom software application
development, CAD, production planning, document management, ERP
systems, MES manufacturing systems, shop floor control, accounting and
finance systems. Championed process based URS, FRS documentation and
process-centric SIT, FAT, SAT/ OQ testing. Co-authored basic
methodology for CFR 21, “How to Part 11” compliance for global
consulting group. Consulting in Assembly, Electronics, Facilities,
Pharmaceutical, Chemical, Food, and Discrete Manufacturing. Developed 6
Sigma based Technology Acquisition methodologies.

EXPERIENCE 9/2002 – Present
TIGBE Consulting Group Ltd Philadelphia, PA
Totally Integrated Global Business Excellence Consulting Group ltd.,
Philadelphia, PA

Sr. Project Manager / Consultant / Sr. Operating Partner – for
boutique Global Technology Consulting firm focuses on the regulated and
near regulated industry. Responsibilities include Business Plan and
Market Plan for a Global Consulting Partnership, staff acquisition and
management, profit/loss oversight. Projects include:

Genentech, South San Francisco, CA Corporate IT Global Manufacturing
Portfolio Manager – served as a consultant in corporate IT PMO acting
as an employee leading strategy, structuring and restructuring of $150M
IT portfolio, Approved Project chartering and budgets for replacement
of every major system including ERP/SAP interfaces, MES/POMS, Tracking
Systems/Trackwise, EDMS/Livelink, CIM, PLM, EAI, Clinical Systems Mfg
solutions, Quality Systems, Batch History Systems, Warehouse Systems,
Wireless, Citrix Platform update, as well as systems for new bio-tech
Mfg facility, new distribution facility, etc. Prepared portfolio
strategy and prioritization, initalized compliant SDLC methodology,
review and reengineering of PMO processes, established Portfolio
Prioritization Strategy Program, analyzed and architected technical
solutions and roadmap for portfolio, oversaw PROP PMO project
management staff, performance reviews, restructuring staffing, change
management, consulted with Senior Leadership on various portfolio
issues, including recommendations for project governance, change
management, outsourcing, validation and quality policy improvements.
Wrote 2010 plan for portfolio. Also identified and implemented PMO
processes, project portfolio quality and performance metrics, Reviewed
documentation standards and made recommendations, Created and
restructured Project delivery staffing plan and staff. Directed staff
of 150 Employees/contractors in a matrix organization

TIGBE, Project Manager –projects include, hands on development and
implementation of website www.tigbe.com, including all web content,
also marketing materials and training materials for staff and
consortium & client partners- including CFR21 Part 11, Validation,
PMI-compatible Project Management Training, ethics and 6 sigma training
for staff, and definition of a fast track SDLC, with initial focus on
process based /physical / data structure requirements definition.
Services included project auditing and regulatory consulting. Current
project is developing a suite if technology acquisition/
implementation/ remediation methodologies based on 6 Sigma principles.

Schering Plough, NJ, PMO Project Manager / Operational Quality Reviewer
Consultant – leading 21 CFR Part 11 systems remediation effort in a
pre-clinical environment. Responsibilities Review and Audit of Lab
Systems Validation packages, quality reviews, Remediation Plan
development, SOPs and project methodology development, overseeing
Capital funding process, preparing Appropriation Requests and
monitoring project progress

7/2000 – 8/2002 Honeywell-POMS Herndon VA
Project Manager
PM for Automation Software services utilizing Oracle/NT.MES software
projects in Pharmaceutical/Cosmetics/Chemical Industries. Prepared
reorganization plan for CEO for POMS Product development and Services.
Typical responsibilities included Project management, 80% travel
globally, customer interaction and team building. Projects included:
Merck, Sharpe and Dome, West Point, PA, Sr. Lead Testing Consultant –
trouble-shot testing/validation effort, refocused team for processed
based testing of integrated discrete/bulk weigh dispense application.
Review/Analysis of Testing Plans. Evaluation/development of Disaster
Recovery procedures. Merck Project methodology evaluation.
Pharmacia – Aerceibo, Puerto Rico, Sr. Lead Testing Consultant –
development of IQ/OQ testing for custom material movement system/weigh
dispense application integrated to automated WMS and SAP for
green-field bulk processing/Dry Powder manufacturing operation.
Proctor and Gamble, Hunt Valley, MD, Sr. Lead Testing Consultant – Site
Management/led SIT/FAT OQ process based testing effort testing of
customized bulk weigh dispense operations for multi-site batch produced
powder and liquid cosmetics manufacturing operation, including
Integration testing with Mercator-based SAP interface to remote Oracle
server.
General Electric Plastics –USA/, Mt. Vernon, IN, Project Manager/ Sr.
Consultant –reviewed proposed project plans for multi-plant global
custom plant automation project; functional analysis of manufacturing
and lab systems & integration requirements for existing GEP Systems.
Project was for System design and implementation of a global 6 Sigma/
Lean Manufacturing to improve yield and quality of output bulk Lexan/
Acrylic continuous process defined 6 Sigma user requirements..
General Electric Plastics – Asia Pacific, Singapore – Project Manager –
managed, directed User Requirements for dock to dock MES application
for Benoi China, Singapore, and Nansha China Lexan Finishing Plants.
Operations/Systems analysis integration including to plant floor and
lab systems. On-site seminars, preparation of technical proposal and
prototype solution. Consulted and provided recommendations for System
design and implementation of a global 6 Sigma/ Lean Manufacturing to
improve yield and quality of output bulk Lexan/ Acrylic continuous
process per defined 6 Sigma user requirements.

Wyeth Labs, Special Consultant – Global CDS Automation effort –
analysis/recommendations for Global MES standard for green-field
Singapore manufacturing facility; Analysis/project support – Newberg,
Ireland dispense system.
Rouses Point, NY – Project Manager for roll out of customized
integrated Computerized Dispense System application.
Support/development/refinement of site-specific user requirements
POMS European Operations, Brussels, Special Assignment Project Auditor/
Consultant to CEO. – Brussels, Belgium. Audit, analysis, and
recommendations for global project execution improvement included GAMP
centric project implementation methodology, establishment of enterprise
Version Controlled documentation & code repository, improvements in
resources assignment methodology, improvement of fiscal
tracking/reporting, establishment Project Quality Assurance/ Quality
Control for projects and a reorganization of the corporate structure
for appropriate Project audits, improvement to product development /
project execution methodology, technical improvements for base product.
Consulted and provided recommendations to provide improvements to
software development, testing and implementation process for 6 Sigma
project to improve delivery of ERP (JDE & SAP) integrated turnkey
Manufacturing Execution Systems software.

2/1998 – 7/2000 Raytheon Consulting & System Integration Philadelphia,
PA
Group Leader
Sr. Consultant/Manager, AUTOMATED SYSTEMS, Life Sciences Practice –
for IT and MES implementation. Technology evaluation for Life Sciences
Practice including Pharmaceutical, Nutraceutical, Biotechnical
Industries. Validation & POMS Trainer, directed POMS development
system. Directed MES, LIMS, APS, ERM, Document Management, Biometric
technology evaluation. Coauthored “How to Part 11” compliance program
for 21CFR Part 11. Business development responsibilities for Life
Sciences Practice-included cold calling, marketing and sales
presentations, development of Marketing Brochures, account strategies,
proposals. Training included development & implementation of POMS MES
training program for global Consulting/Systems Integration
organization. Projects included:
Darja Laboratories- Project Manager -Startup POMS project for
green-field, startup mfg. facility for bulk processing and packaging
for an entrepreneurial R&D organization. Managed team of consultants
with custom MES implementation to PLC & Level2 software for control
system, PLC programming, control system design, process engineering
services, and electrical distribution system for facility. Provided
broad-based Business & technology consulting & Business process
reengineering.
Merck- Sr. Consultant -POMS training for POMS Clinical Manufacturing
Integration and Implementation proposal.
Bayer H&R- Sr. Lead Consultant, analysis/recommendation of technology
requirements for global POMS MES / ERP/ SCADA Integration proposal.
Schein Pharmaceutical – Sr. Consultant – review of Business Processes &
recommendations regarding VPN infrastructure & AOPs for Business groups
& IT.
Pharmacia-Upjohn- Sr. Lead Consultant – analysis of Business/Mfg.
Process integration utilizing various ERP & SCADA for Domestic/European
initiation program of POMS MES.
Millenium Chemical – Sr. Lead Consultant -analysis of WAN/LAN and
Process Control deployment of IT infrastructure including SAP
deployment in conjunction with Y2K System identification, remediation
project.
Colgate-Palmolive, Corporation, Sr. Lead Consultant, Hills Pet
Nutrition Division,
Lead Consultant for corporate sponsored Y2K Compliance Project for
large food process mfg. facilities to identify non-compliant systems,
equipment, and instruments requiring remediation plans for Hill’s
division. Responsibilities- Compliance training Corporate personnel for
multiple mfg. Facilities, directed Planning and Awareness, Inventory,
and Triage Phases for flagship facility with integrated SAP/WonderWare
MES.
Vlasic Foods International, Project Manager – Cherry Hill, NJ, Food
Manufacturer, Lead Consultant – enterprise Document Management System
proposal for domestic and Global operations.
General Electric, – Industrial Controls Division, Project Consultant
-coordinated Y2K compliance research qualifying vendors, specifying
status for compliant/non-compliant systems, equipment, and instruments
for 12 facilities.

11/1997 – 2/1998 Bolder Designs Prospect Park, PA,
Director of Training & Consulting Services
Bolder Designs – Prospect Park, PA,

3/1995 – 11/1997 RAMA Display Bensalem, PA & Henderson, NV
Director of IT

4/1988 – 3/1995 Strawbridge & Clothier Philadelphia, PA
CAD System Manager / System Analyst Retailer, CAD System Manager /
System Analyst

10/1986 – 3/1988 KPA Associates Philadelphia, PA
Project Manager A/E Consulting firm to Fortune 500 firms.

1/1984 – 9/1986 KSO Industries Hatfield, PA
President /CEO Electronics components Manufacturer – EMI/RFI Shielding
& Chip Carrier, Display & PC Board Connectors, Managed and established
40 employees,

 

  • Updated 1 year ago

To contact this candidate email robbkavanagh@hotmail.com

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