Senior Validation Consultant

Senior Validation Consultant, with twenty years’ plus experience with growth in roles and responsibilities in instrumentation, process, validation, temperature mapping and FDA interaction in the medical device, manufacturing, and pharmaceutical areas of the Life Science industries, by successfully completing numerous projects on schedule and budget.

Areas of Expertise

Protocol development and execution of Installation Qualification, Operational Qualification, Process Qualification and Performance Verification protocols, 21 CFR Part 11 and 21 CFR Part 820, Final / Summary reports, HVAC, Temperature Mapping, Standard Operation Procedures, GAMP 5, Software validation, Software Development Life Cycle, data analysis, periodic reviews, resolution of Corrective and Preventative Actions, Cleaning (CIP, COP, SIP) validation, Remediation of 483s, Test Method Validation (TMV), Training and TMV operator certification, Solid dose, Liquid, spray drying, Quality Assurance, Process/Design Failure Mode Effects and Analysis, Aseptic processes, Facilities, Utilities

Employment History

Senior Validation Consultant

BRT (Medical Devices)

March 2018 – Present

Creation of qualification protocol for MISys Software application

Senior Validation Consultant

Catalent Pharma Solutions (Biopharmaceutical)

October 2017 – December 2017

Completed Gap Analysis on Validation Binder for a chromatography skid and created necessary documents to complete the qualification

Completed the Validation binder by creating documents to qualify a microbial detection system

Resolved numerous deviations to close out validation binders

Created necessary documents to complete the Validation Binder for an isolator

Senior Validation Consultant

Unipharma USA (Medical Devices)

March 2017 – June 2017

Created User Requirement Specification for new Blow-Fill-Seal aseptic machine equipped with automatic SIP cycle in new facility

Created User Requirement Specification for new Blow-Fill-Seal aseptic machine equipped with manual SIP cycle in new facility

Created Installation and Operational Qualification for new BFS aseptic machine equipped with automatic SIP cycle in new facility

Created Installation and Operational Qualification for new BFS aseptic machine equipped with manual SIP cycle in new facility

Completed dry runs on Installation and Operational Qualifications to eliminate deviations during the validation effort.

Created and revised Standard Operational Procedures for new BFS aseptic machine equipped with automatic SIP cycle in new facility

Created and revised Standard Operational Procedures for new BFS aseptic machine equipped with manual SIP cycle in new facility

Senior Validation Consultant

Tolmar (Medical Devices)

August 2016 – February 2017

Created, revised and executed IOQ protocol for new Nitrogen system (tanks and vaporizers)

Created, revised and executed Performance Qualification for expanded Nitrogen system

Created and executed Change Control documentation to activate new N2 tanks and vaporizers and to retire existing N2 tanks and vaporizers

Created and executed IOQ protocol for new Tray Sealer

Created and executed Performance Qualification protocol for new Tray Sealer

Created IOQ protocol for new Syringe Labeler

Completed dry runs on IOQs to eliminate deviations during the validation effort.

Created performance qualification report template to close out completed qualifications

Revised site validation master plan to reflect ongoing qualifications

Senior Validation Consultant

Confidential (Medical Devices)

November 2015 – August 2016

Completion of numerous IQ, OQ, and PQ protocols for newly installed equipment

Senior Validation Consultant

Cordis (Medical Device)

May 2015 – October 2015

Validation of a SPC application utilized by multiple franchises by creating documents according to SDLC methodology; Compliance Analysis, Compliance Plans (Core and Wave installation), User Requirement Specifications (URS), Risk Assessment (FMEA), Functional Specifications (FS), Traceability Matrix (TM), User Acceptance Test (UAT) Protocol and UAT Test Scripts

Validation Consultant

Swiss Caps (Medical Device)

March 2015 – May 2015

Completed validation protocols for new production lines, including vertical encapsulators, chain conveyors and tumbler dryers, ahead of schedule and under budget

Revised existing operating instructions for new vertical encapsulators, conveyors and tumbler dryers, ahead of schedule and under budget

Created cleaning procedures for new tumbler dryers, ahead of schedule and under budget

Senior Validation Consultant

Siemens (Medical Device)

July 2014 – February 2015

Revalidated several liquid nitrogen rapid freezer systems, in compliance with recently revised quality system documentation

Revised SOPs for rapid freezer systems to reflect current operating procedures

Revalidated several V-Blenders in compliance with current quality system documentation

Created and executed process validations for the rapid freezer systems

Senior Validation Consultant

Promega (Medical Device)

January 2014 – July 2014

Completed validation of Building Automation System, which controlled the HVAC system to provide conditioned air to a new 213,000 square foot In-Vitro Device Manufacturing Center on schedule and budget, which involved intensive collaboration with system vendor and client to resolve system issues.

Completed validation of several Particle Monitoring Systems to monitor the ISO classification of the environmental conditioned rooms on schedule and budget. Project involved intensive collaboration with the system vendor and the client to resolve system issues.

Completed dry runs on Installation and Operational Qualifications to eliminate deviations during the validation effort

Completed temperature mapping of several warehouse areas in accordance with the qualification protocols.

Assisted in qualification of a new compressed air system.

Independent Validation Consultant

Biomet 3i

November 2011 – June 2013

Validated web based portal for client interaction (Alpha, Beta, Commercial versions)

Validated numerous Post Market Surveillance Workbooks based on Excel spreadsheets

Independent Consultant

Cordis

November 2010 – September 2011

Participated in process improvement project to minimize extrusion machine set up time during product changeover by performing numerous Design of Experience scenarios

Created and executed process validations for the various extrusion machines

Project Manager, Project Leader, Validation Engineer

Stelex-TVG

April 1997 – October 2010

Managed validation of automated vision systems including software within schedule and budget.

Completed multiyear product transfer within facilities with adjustments to accommodate production requirements within the predetermined schedule.

Closed a CAPA - resolved the component tolerance stack up between sites.

Validated inspection equipment to be relocated to another facility within the proposed schedule.

Revalidated numerous inspection equipment due to a laboratory expansion, while maintaining the functionality of the laboratory. This effort closed a CAPA and ensured that the equipment was in compliance with Part 11.

Created and executed process validations for the various braiding machines

Created Software Requirement Specification and Software Validation Protocol for computer based simulation system for GMP and Part 11 compliance, used by New Product Development group.

Supervised team of engineers / specialists in developing and executing IQ and OQ validation protocols and summary reports for a new addition to an existing oral dose manufacturing facility. New equipment included a spray tower, dust collectors, post hoist, and air handling units.

Directed team of engineers / specialists in developing and executing Test Method Validation (TMV) protocols and summary reports for an existing medical device manufacturer.

Managed engineers and specialists in validation of a sterile medical device manufacturing facility to meet approved schedule and budget

Managed validation of a new addition to an existing sterile manufacturing facility to meet the clients schedule and budget

Created and executed cleaning (SIP) validation protocols for batching tanks, which involved spray ball coverage testing and chromatography columns in a sterile pharmaceutical manufacturing facility.

Created and executed cleaning validation protocols for batching tanks, mixers, blow-fill-seal machines and clean rooms in a sterile pharmaceutical manufacturing facility.

Education and Training

Degree, Power Technology, Williamson College, Media, PA.

Ongoing training, 200+ Courses, Programs, Procedures

Selected Pharmaceutical / Medical Device Clients

Bayer, Oakland, CA

Bioport, Lansing MI Parke Davis, Holland, MI

BOC Gases, Berkeley Hts., NJ Pepsi, Port Chester, NY

Catalent Pharma Solutions, Madison, WI Procter & Gamble, Cayey, PR

Cordis, Miami Lakes, FL Procter & Gamble, North Norwich, NY

Cordis CNV, Miami Lakes, FL Promega, Madison, WI

Eurand, Dayton, OH Siemens, Newark, DE

Johnson & Johnson, New Brunswick, NJ Tolmar, Fort Collins, CO

McKesson, Shawnee, KS Unipharma, Tamarac, FL

Merck, Aerocibo, PR Vital Pharma, Riveria Beach, FL

MG Industries, Port Arthur, TX Warner Lambert, Morris Plains, NJ

Monsanto, Augusta, GA Whitehall Robins, Richmond, VA

Neopath, Richmond, WA Wyeth, Pearl River, NY

OMJ, San German, PR

Selected Utility and Equipment

Utility Systems

Classified Environments

Compressed Gases

Heating Ventilation and Air Condition (HVAC)

Building Automation Systems

Deionized Water (DI)

USP Water

Water For Injection (WFI)

Clean Rooms

Compressed Air

Clean Steam

Steam In Place (SIP)

Clean In Place (CIP)

Uninterruptable Power Systems

Process Equipment

Instron

Laser Mikes

Stability Chambers

Chromatography Columns

Mixers / Agitators

Automatic Pneumatic Transfer Systems

Isolators

Fume Hoods

Molding Machine

Fusing Machine

Tumbler Dryers

Chain Conveyors

Chromatography Skid

MicroVu

Smart Scope

Hydraulic Burst Leak Tester (HBLT)

Blow Fill Seal Machines

Blister Machines

Tablet Machines

Encapsulation Machines

Holding and Mixing Tanks

Balloon Blowing Machine

Braider

Tray Sealer

Microbial Detection System

Optical Comparator

Pan Coater

Tray Dryer

V Blenders

Ovens

Lyophilizers

Depryogenation Ovens

Automatic Syringe Filling Systems

HEPA filters

Extruder

Air Handling Unit

Vertical Encapsulators

Syringe Labeler

Aseptic Processing Workstation

Reactors

ETO Sterilizers

Steam Sterilizer

Hydrogen Peroxide Sterilizers

Autoclaves

Tray Washers

Equipment Washers

Packaging Systems

Vertical Coating / Drying Systems

UV Curing Fixture

Mitutoyo Vision System

Vertical Centrifuges

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