Validation Compliance Group, LLC
Mar 2011 - Present Principal Validation Consultant, Boston Scientific Fremont, California
Developed and guided the tapered sheath OQ/PQ plan & execution
Audited and developed Master Validation Plan for the Core wire grinding manufacturing area.
Closed out validation report for the RDN Taper Puller-Cutter
Jan 2010 - Mar 2011 Relocation Expansion Project, Advanced Bionics Valencia, California
Performing Validation Facility transfer. Implementing Master Validation Plan. Generate equipment
list from the manufacturing areas.
Process validation for Resistance Welders, Medical Tray Sealer, T-Microphone. Scheduling
Validation activities with production, facilities and manufacturing engineering.
Aug 2009 – Oct 2009, FDA Remediation Project, Arkray, Group, Kyoto, Japan
I was part of a team that was involved with FDA remediation. My role was statistical techniques
using 21 CFR part 820.250, ISO 13485, and ISO 2859-1.
Creating a Quality Engineering team to exercise quality approach within the QE team which
included representatives from the following areas; CAPA, Non-Conformance, Validation, System
Analysis, & Supplier control.
Feb 2009 – Aug 2009, Process Development Consultant, Boston Scientific
Electrophysiology San Jose, CA
Process Development for the Cryogen Balloon Ablation System. Processes to include but not
limited to inspection vision system, balloon vacuum/pressurized system, swaging process.
Gage R&R, process capability, normality analysis and correlation studies on different parts of the
Cryogen Balloon Ablation System.
Performed Attribute & Variable Test Method validation using Boston Scientific Corporation
Software utilized for statistics was MiniTab 15 Statistical Software
Jan 2009 – Feb 2009, Principal Validation Consultant, MannKind Corporation, Danbury, CT
Commissioning of indirect impact utilities: Chilled water, Plant steam, Instrument air, Electrical
system and Emergency power system, and Process waste water.
Oct 2007 – Dec 2008, Principal Validation Consultant, Boston Scientific Neuromodulation,
Implemented and performed Attribute & Variable Test Method validation using Boston Scientific
Corporation guidelines at the Valencia facility. Was appointed “approved signature authority” for
the Director of Validation for the review and approval of approximately 110 validation protocols and
reports. Was part of the Sylmar/Valencia "Phase I Move" validation. Was a team member in the
FDA site approval for the Building 55B, Valencia Facility. Was the liaison for the Validation Project
Manager in assisting validation activities with other validation consulting agencies and Boston
Scientific employees. Streamlined new Installation, Operational and Process Validation protocols
and reports. Was responsible for the process validation of the SCS II Implantable Pulse
Generator. Worked on Failure Modes Effect Analysis, and Master Validation Plans/Reports.
Performed and executed to include but not limited to the “Precision Automated Laser System, Laser
welding, and vacuum bake” which was identified by the FDA as a critical process. Assisted in
training personnel with Minitab version 15, to accomplish statistical data in the validation reports.
Attended “Effective Business Writing” and “Process Validation” seminar. Was a volunteer for the
"Make a Difference Day 2008" in Valencia, CA.
Mar 2007 – Oct 2007, Validation Consultant, Alpharma Pharmaceuticals, Piscataway, NJ
Prepared, executed, and reported IQ, OQ, PQ for the R&D suite renovation project to include but not
Power Scientific stability chambers, US Filter compressed air system, McQuay & Trane HVAC
systems, DEA Vault, Portable Sampling Booths & Laminar Flow Booths. Gap Analysis for the
existing validated utilities.
Jun 2006 – Dec 2006, Validation Project Engineer, Boston Scientific, Medical Device,
Prepared, executed, and reported 44 IQ/OQ/PQ for extrusion pressure coating process, single
lumen tubing, multi-lumen, multi-layer extrusion and braiding processes for the “Horizon” project.
Exposure and involvement with Windchill Product Data Management (PDM) for all documentation
creation and modifications.
Apr 2006 – Jun 2006, Validation Consultant, Chesapeake Biological Laboratories,
Contract Manufacturer, Baltimore, Md
Write Periodic Review of critical equipments throughout the facility. Write IOQ protocols for
Terminal Sterilizer, Refrigerators, and the Compressed Air Systems. Identified deviations, CAPAs,
Change Control, calibration, for the equipments that were scoped out on the assignment. Write
addendum to the existing Compressed Air System. Worked with the drafting engineer to improve
P&ID drawing for the compressed air system and the process air drop architecture drawing.
Received Good Documentation Practices training.
Oct 2004 – Mar 2006, Validation Project Engineer, Boston Scientific, Medical Device, San
Jose & Fremont, Ca
Managed the extrusion project at the Fremont facility to include validating 34 extruded parts within
19 processes. Implemented and updated existing Legacy systems to current standards. Prepared
and performed Failure Mode Effect Analysis for the extrusion pressure coating process, single
lumen tubing, multi-lumen, multi-layer extrusion and braiding processes. Prepared and executed
OQ/PQ for extrusion pressure coating process, single lumen tubing, multi-lumen, multi-layer
extrusion and braiding processes. Process improvement for the Steeger Braider processes to
include but limited to establishing preventive maintenance procedures and implementation, and
tooling improvements. Exposure and involvement with Windchill Product Data Management (PDM)
for all documentation creation and modifications.
Jun 2004 – Aug 2004, Validation Engineer, Amgen Bio-Pharmaceutical, West Greenwich, RI
Executed OQPs for the BioNext Project qualifying CIP Skids, Buffer/Media/Harvest tanks &
Bioreactors. Conducted in-depth Installation qualifications both visually and accessing Enhanced
Turn-Over Package (ETOP) binders for certificates, purchase reqs, and cleaning & passivations for
piping/instrument installation constructs. Verified/Redlined versioned P&IDs against a visual-as-
built status of CCA/WFI/Steam lines for tanks & utility skids.
Validated soft phases within DeltaV Manufacturing Execution System that monitored CIP/SIP
recipes for Media, Buffer, Perfusion systems. Executed functional tests, control loops, & alarms
reflective of project requirements & design document during Operational qualifications. Retrieved
Batch Event journals, within Batch Editor of DeltaV, plotted Pi Historian graphs as output attachment
Apr 2004 – Jun 2004, Validation Engineer, Cryonix, Repository/Relocation/Clinical Trial
Support, Transportation, Security, Rockville, Md
Validated 24-hour temperature monitoring system (data acquisition and control system - DACS)
with annual probe Calibrations to include freezers, walk-ins, and ambient temperature storage.
Aug 2003 – Apr 2004, Validation Project Manager, Pfizer, Global Research & Development
Managed validation renovation project schedule for the Liquid Dosage Manufacturing. Designed
and managed validation activity spreadsheet for the project’s equipment. Writing IQ, OQ, and PQ
for Lyophilizer Equipment
Writing Validation Master Plan, which served as a guide to the overall strategy for
qualification/validation directly, associated with the 2004 renovation project.
Mar 2003 – Aug 2003, Validation Engineer, ITC, Medical Device Corporation, NJ
Project engineer managing protocol preparation and executions. Writing Performance
Qualification for automated filling machine. Writing IQ, OQ and PQ for primary packaging line.
Writing Validation Plans design qualification for new process equipment.
Jul 1999 – Mar 2003, Senior Project Engineer, Integrated Project Services, Hillsborough, NJ
Medical Device, Pharmaceuticals, & Bio-tech Consultant. Senior Project Engineer
1998 – Jul 1999, Nycomed Amersham, South Plainfield, NJ
Manufacturing Engineering. Validation Engineer
1993 - 1998, CORDIS, Johnson & Johnson, Warren, NJ
Extrusion & Packaging Engineering. Senior Operations Associate
1988- 1993 United States Air Force, Air Force Intelligence Command
Aug 1990 – Sep 1992, Royal Air Force Base Mildendenhall, United Kingdom
Jun 89 - Aug 1991, Hellenikon Air Base, Greece
|Validation & Compliance is
what we do.