|July 2014 - Present, Principal Quality Consultant, (Redbock), Atrium Medical, Nashua, NH
Facilitated in the Product Line Re-qualification for the iCAST balloon expandable stent.
Reviewed & approved documents to include but not limited to OQ, PQ, process capabilities analysis, Preventive Maintenance (PM) and Calibration.
Assist in the creation of PM procedures and setting up critical equipment traceability records with the calibration department.
Gap analysis and remediated on retrospective extrusion records to meet current company's SOP requirements.
Qualifications included: Single Lumen tubing, 3 Lumen Catheter Shaft, Test Method validation for the LaserLinc System & UG+ Average Wall Thickness and ID Measurement.
May 2014 - July 2014, Principal Consultant, Validation Compliance Group (VCG1)
Process validation project development.
Mar 2013 - May 2014, Director of Process Validation, (EngiSystems)
Alcon Manufacturing, Houston, Texas
Project Manager, Maximo Remediation
Provided leadership within the core team to maintain the vision and strategy established by Alcon and EngiSystems upper management to execute the following:
Review CAPA and provide Gap assessment for MAXIMO Preventive Maintenance program’s state of compliance per 21 CFR part 11.
Deploy team with clear objectives and empower team leaders to act with accountability.
Execute plan by developing operational SOP’s, work flows, and job aids.
Implementation: Work orders, facility drawings, job plans and PM’s are now in a secured qualified Document Controlled Management database oppose to the previous paper based
system. Qualified equipment have standardized nomenclature for ease of traceability of location.
Feb 2013 - Apr 2013, Sr. Compliance Quality Consultant, (PAREXEL) Ben Venue Labs, Bedford, OH
Consent Decree Auditor
Dec 2012 - Feb 2013, Sr Quality Consultant, Synthes, Johnson & Johnson, Mezzovico, Switzerland
CFR 21 Title 21, Part 820.90; Nonconformance Report remediation for the surgical treatment of bone fractures processes.
CFR 21 Title 21, Part 820.40; Document Control Order remediation for the surgical treatment of bone fractures processes.
Jul 2012 - Nov 2012, Project Director Consultant Precision Spine, Pearl, MS
Implement Quality Management System to include Control of Documents, Handling – Storage and Distribution, Production & Process Control, Process Validation, Risk Analysis,
Statistical Techniques, Master Validation Plan, Risk Management, Gage R&R Calibration & Preventive Maintenance.
Manage Process Validation Programs & Training:
Manage validation program for the Anterior Lumbar System in order to ensure regulatory compliance and current good manufacturing practice.
Logistical plan for execution:
Determination of efficiencies for subsequent phases of process validation
Master Validation Plan, update and approve procedures, templates and forms.
Execute Measurement System Analysis (MSA) and Validation Quality Analysis (VQA) documentation • Training of the validation program
Dec 2011 - Jul 2012, Quality Consultant Zimmer Spine, Minneapolis, MN
Identifying risk hazards according to ISO 14971 & 13485 associated within the client’s product lines, estimating and evaluating potential risks of those hazards. Mitigating and
controlling the risks and monitor the effects of the current controls.
Supply Chain Quality:
Investigating and facilitating supplier change notification, review and approval. • Calibration:
Investigating and sustaining the current Calibration Alert process.
Mar 2011 - Nov 2011, 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
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 guidelines.
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, Valencia CA
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 limited to
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, Fremont, Ca
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 submittals.
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
Aug 2003 – Apr 2004, Validation Project Manager, Pfizer, Global Research & Development Corporation, Ct
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
SCHERING PLOUGH - Summit, NJ 3/2003 Validation Engineer
• Writing Compressed Air IQ, OQ protocol & HVAC IQ & OQ protocols
ANDRX 12/2002 Validation Engineer
• Troubleshoot and execute the Compressed Air system to include non-viable testing, moisture analysis, particulate testing, and Oil/mist test
BLISTECH CORPORATION 7/2002 Project Manager
• Writing and performing FAT, IOQ protocols for Packaging line to include, Unscrambler, Capsule feeder, Cottoner, Capper, Induction Sealer, Retourquer, and Labeler
CARDINAL HEALTH 6/2002 to 12/2002 Project Lead
• Perform IOQ and PQ qualifications for the new utilities to include HVAC System, Compressed Air, and Chiller system for the new expansion facility
SIDMAK LABORATORIES 4/2002 to 06/2002 Project Lead
• Perform IOQ and PQ qualifications for the new utilities to include HVAC System, Compressed Air, and Chiller system for the new expansion facility
CLAY PARK LABORATORIES 3/2002 to 4/2002
• Complete Installation and Operational Qualification for the 2 HVAC systems
HOFFMANN-LA ROCHE 9/2000 to 3/2002
• Awarded Process re-qualification on all utilities (clean steam, water systems etc.) in the facility $700,000
• Temperature Mapping proposal for all warehouses in both Nutley and Totowa awarded
• Installation and Operational Qualification of HVAC system
• Gap analysis on existing critical utilities at both Nutley and Totowa facility
TARO PHARMACEUTICALS, Haifa Bay, Israel Project Lead 7/2000 to 9/2000
• Establish a Validation Master Plan for the Haifa Bay, Israel facility
• Performed audit at the facility
BECTON DICKINSON TRANSDERMAL SYSTEMS 7/2000 to 9/2000
• Performed an Installation and Operational Qualification for a Thermoforming Packaging Machine, model # Prime PV9000
PURDUE PHARMA L.P. PHARMACEUTICAL 5/2000 to 6/2000
Sr. Validation Engineer
• Currently assisting the client on modifying a Fluid Bed Processor, utilizing a modification qualification protocol. Items that needed to be identified are as follows:
• Recipe specific alarm verification Security Level Function verification
• Front end computer screens modification
• Batch record retrieval and storage
• Replacement calibration of flow elements
• Transmitter re-scaling
CHEMO DYNAMICS L.P.12/1999 to 5/2000
• Managed and lead a team of 2 validation engineer in the completion of 2 reactor enclosures, with the following ancillary equipment:
10 ton Chiller
ALMEDICA CORPORATION 12/1999 to 3/2000
• Successfully qualified a HVAC system for a Class 10,000
• Submitted proposal and was awarded job for $35,000
• Submitted 2nd proposal and was awarded job for 14 Carrier HVAC and one BAS system
BERLEX LABORATORIES 9/1999 to 12/1999 Project Lead
• Managed and lead a team of 1 validation engineer and 1 validation specialist in completion of the
• Project was over $50,000 and completed on schedule
• Installation and Operational qualification was performed on the following pieces of equipment:
Fume Hoods (12 units)
Glassware Washer (2 units)
Compressed Air Distribution o Electrical Distribution
Compressed Lab Gases
PURDUE PHARMA L.P. PHARMACEUTICAL 7/199 to 12/1999 Project Lead
• Managed and lead a team of 2 validation engineer and 3 validation specialist in completion of the
• Project was over $100,000 and completed on schedule and under budget by 10%
• Installation and Operational qualification was performed on the following pieces of equipment: •
York, 300 ton chiller
Two York, HVAC systems
Building automation systems
Vac-u-max, vacuum transfer system o Niro, Fluid Bed Dryer
Integrated Project Services Eagle Award.2001
Integrated Project Services Eagle Award 1999
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.