Engineer Validation

Summary

Qualifications

•Over Twenty years of biopharmaceutical/medical device experience

•Medical Device experience

•Twenty years of facility and manufacturing commissioning experience

•Fifteen years of process & equipment validation experience

Summary of Capabilities

SIP/CIP Cycle Development – SIP/CIP systems and cleaning cycle evaluation and optimization.

SIP/CIP System Validation – Author and execute IQ, OQ, and CV or PQ protocols. Manage process cleaning development activities.

GMP Documentation – Author and review Standard Operating Procedure and Policy documents for change control, lifecycle, validation program, qualification protocols, operating manuals, computer system validation documents, and sterilization studies.

Utility Commissioning/Qualification - Perform commissioning and validation on WFI, Compressed Air, and HVAC Systems

Equipment Commissioning – Perform commissioning and validation services; author and executed commissioning plans.

Compliance Services - Knowledge of cGMP regulations, 21 CFR standards.

Professional Experience

GSK, Collegeville, Pa. 12/2016 to Present

Validation Engineer

Authored Validation Documentation, Validation Plan, Design Installation Qualification, Operational Qualification, Performance Qualification, for Kaye Valporbe dataloggers

Authored Data Integrity Assessment documentation for Karl Fisher Coulometer, Brookfield Viscometer, and Agilent HPLC systems

Spark Therapeutics, Philadelphia, Pa. 7/2016 to 11/2016

Validation Engineer

Authored and executed Installation and Operational Qualification protocols for new Quality Control Laboratory upgrade. Equipment included CO2 incubators, -80ºC freezers, stability chambers, walk-in cold rooms, and all equipment needing qualification.

Assembled and finalized protocol data pack for client approval

Alcon Surgical, Sinking Spring, Pa. 09/2014- 7/2016

Validation Engineer

Authored and executed re-validation protocol for autumn and winter temperature/relative humidity mapping for warehouse to close a corporate CAPA.

Authored and executed re-validation protocol for residual Ethylene Oxide / Ethylene Chlorhydrin amounts for all product families manufactured at Alcon to close a corporate CAPA

Authored and executed validation documents (IQ, OQ) for new particle counter.

Authored and executed validation plan and protocols for Sterile Barrier System packaging aging studies. Generated shipping study test scripts, organized and analyzed shipping data from outside testing laboratory.

Coordinated and documented Real Time aging testing for open protocols.

Performed Re-validation assessment on Microbiology equipment.

McNeil Laboratories, Lancaster, Pa. 9/2013-5/2014

Validation Engineer

Gap Assessment-Reviewed and composed documentation for remediation of equipment

and utilities gaps in existing qualification documentation and the new Commissioning

and Qualification program under the Consent Degree Program

Performed gap remediation review for Solids Processing, Girton Washer, Compressed Air, USP Water, High speed Bottle Line, and Blister Packaging Line.

Morphotek Inc. 1/2013-9/2013

Validation Engineer

Production Centrifuge– Wrote and executed IOQ for Westfalia production centrifuge. Assembled data packs and wrote final summary report and investigated all deviations.

Santimatic Portable CIP Skids– Wrote and executed IOQ’s for two Santimatic portable CIP skids. Assembled data packs and wrote final summary and investigated all deviations.

Wave Bioreactors- Wrote and executed IOQ’s for three GE Healthcare wave bioreactors. Assembled data packs and wrote final summary and investigated all deviations.

Temperature Controlled Units- Performed temperature mapping on Dometic -70 C freezers using GE, Kaye Datalogger.

Sanofi Pasteur-Controlled Temperature Environment 8/2012-1/2013

Execution Lead

Autoclave Validation – Performed Cycle Development, Load ranking, and Performance Qualification on the Production Autoclave. Assembled data packs and wrote and investigated all deviations.

Ben Venue Laboratories-via ANJ Engineering (Validation Engineer) 3/2012 – 8/2012

Supplemental Validation – Wrote and executed Supplemental IOPQ protocols to address and close gaps identified in periodic reviews performed on 7 MECO WFI Distillation units throughout the plant. Execution involved resolution of all deviations and writing a Summary Report for all validation activities.

Supplemental Validation – Wrote supplemental IOPQ protocols to address and close gaps identified in periodic reviews for two (2) WFI loops and Two (2) Clean steam generators, and HVAC Systems

Sanofi Pasteur-Controlled Temperature Environment 8/2011-3/2012

Execution Lead

Temperature Mapping – Performed PQ temperature mapping on Final and In-Process Cold Boxes, Seed Freezer, and Inoculum Cold Box. Assembled data packs and wrote and investigated all deviations.

Autoclave Validation – Performed Cycle Development, Load ranking, and Performance Qualification on the Decontamination Autoclave. Assembled data packs and wrote and investigated all deviations.

Compli LLC, assigned to Sharp Corporation, Allentown, Pa. 6/2010 – 8/2011

Title: Validation Contractor

Wrote Engineering Study protocols for labelers and pouching machines

Wrote IOQ protocols for checkweighers, gate counters, and vial loaders

Wrote PQ protocols for NJM labeler and Pouching machines

Wrote Packaging Validation protocols for NJM labeler and Bivens cartoner

Executed Engineering Studies on labelers and heat sealer

Executed IOQ on checkweigher, gate counter, and vial loader

Executed PQ and packaging validation studies on labeler and cartoner

Wrote Final Summary report on all executed protocols.

Integrated Service Solutions 1/2010 – 6/2010

Title: Field Validation Specialist

Wrote IQ/OQ/PQ protocols for Incubators, Walk-In Cold rooms, Plate Reader Incubators, -20 C freezers, -80 C freezers

Executed IQ/OQ/PQ protocols for Walk-In Cold rooms, Plate Reader Incubators, -20 C freezers, -80 C freezers using Kaye Validation Equipment

Performed field calibrations as needed.

Hyde Engineering and Consulting 7/2008 – 12/2009

Consultant III

Executed P&ID Walkdown Protocol for utilities (HVAC, Compressed Air)

Executed Operational Assessment Protocol for SIP and CIP

Executed Validation Assessment Protocol for SIP and CIP

Authored Final reports for all executed protocols

Served as team lead for Assessment project

Scheduled all personnel for Project work.

Wrote/Executed cleaning validation development and validation protocols for Bioreactors, manual cleaning, and parts washers

DME Alliance, Allentown, Pa.

Validation Consultant

4/2007-6/2008

Served as Validation Contractor at Sanofi Pasteur, Swiftwater, Pa.

Performed Thermal Validation Studies on Autoclaves, Incubators, and Cold Rooms and SIP

AEROTEK CONSULTING, Chicago, Il

Validation Engineer 06/200*-**-****

• Served as Validation Engineer at .Noramco, Wilmington, De, through VTS.

• Wrote and executed the Design Qualification, Validation Plan, and IOQ for the Next Gen OXY upgrade project.

• Wrote and executed Commissioning Plan for Plant 4 External Chiller

• Executed IOQ for upgrade to Tank Farm Ethanol Distribution

• Wrote Commissioning Test Scripts for additions/changes to new chiller

CIMQUEST INC, Exton PA.

Validation Consultant

10/2006 -4/2007

Served as Validation Consultant at .Centocor, Radnor Pa. and Spring House, Pa.

Wrote Computer System Validation Documents, which included Risk Assessment, Baseline Report, Validation Plan, User Requirement Specifications, User Acceptance Testing, Traceability Matrix, Summary Reports for IOQ and UAT testing on Usiford and FTS lyophilizers, upgrade to GE Labwatch Data Acquisition system, and final validation reports for the following; FTS lyophilizer, Usifroid lyophilizer, and GE Healthcare FPLC.

Wrote a Consolidated Validation Plan and Consolidated Validation Report for additions to the GE Labwatch LIMS system.

Wrote a Qualification Plan and Report for a Brinkmann Metrohm KF Coulometric Titrator

AEROTEK CONSULTING, Chicago, Il

Validation Engineer 06/200*-**-****

• Served as Validation Engineer at .Noramco, Wilmington, De, through VTS.

• Wrote and executed the Design Qualification, Validation Plan, and IOQ for the Next Gen OXY upgrade project.

• Wrote and executed Commissioning Plan for Plant 4 External Chiller

• Executed IOQ for upgrade to Tank Farm Ethanol Distribution

CGI Engineer, Philadelphia, PA

Validation Engineer 1/2006-5/2006

• Served as a Validation Engineer for CDI at Tengion, Winston Salem, NC

• Commissioned and validated Air Handler unit for Class 100 and 100,000 areas

• Commissioned and validated process vacuum system

• Commissioned and witnessed SAT for purified water system.

• Commissioned and validated biological safety cabinets

• Prepared thermocouples for temperature mapping studies.

• Performed temperature mapping studies on a walk-in cold room, cell culture freezer, and incubators.

• Commissioned liquid nitrogen freezers.

ALCAN PACKAGING, Bethlehem, PA

Validation Facilitator 7/2005-01/01/2006

• Served as Manager for 5 outside contractors

• Wrote Performance Qualification protocols for customers as needed

• Managed Calibration and Certification Program

• Maintained time line to meet customer demands

• Attended daily production meetings

• Approved all validation documentation, including protocols and SOP

Compli Consulting, Collegeville, PA

Validation Engineer

1/2005-7/2005

Wrote and executed Cleaning Validation protocols for Centocor, St. Louis, Mo.

Wrote and executed Operational Qualification protocols for Clean Out of Place testing on bioreactors

Developed validation report format for Cleaning Validation protocols

Wrote and executed Experimental protocols for cleaning process

Executed Installation/Operational protocol for ICOS stopper washer, Cardinal Health, Albuquerque, NM

JACOBS ENGINEERING, Conshohocken, Pa.

2003-2004

Validation Engineer

Wrote 5 Protocols for Amgen Lyophilizer Expansion in Puerto Rico

Executed packaging protocols at Merck West Point for Clinical Packaging Line, Bldg 78A on 3 packaging lines

Executed gas system protocols at Merck West Point, Building 82

Wrote Boundary Definition Matrix for Boehringer Ingelheim Bay 33 expansion

Wrote Validation Master Plan for Boehringer Ingelheim Bay 33 expansion

Served as quality inspector for Eli Lilly at Sartorius BBI Systems. Approved parts for fabrication, reviewed all documentation, walked down P&ID drawings, verified all production drawings, performed FAT duties on all manufactured items.

WYETH-AYERST LABS, Marietta, Pa.

2000-2002

Senior Validation Specialist

Wrote/Executed IQ/OQ/PQ Protocols and reports for Utilities, e.g. WFI, HVAC, Clean Steam, Compressed Air, Nitrogen Distribution, CIP, Zebra Labeler and Software, Air Handling Variable Frequency Drives, and Air Handling Units. All Protocols were written/executed to 21 CFR standards where applicable.

Wrote 2 OQ Protocols for Vial Filler Validation

Executed 2 IQ/OQ Protocol for West –Capper

Wrote Final Reports for Vial Filler OQ and West-Capper IQ/OQ

Wrote revision SOP’s on Validation Test Equipment

CENTOCOR, INC., Malvern, PA

1993 – 2000

Metrology Supervisor

1999 – 2000

Supervised 10 calibration contractors and Centocor staff in daily metrology duties

Prepared calibration plans for present and future activities

Trained over 15 metrology personnel in standard operating procedures

Developed calibration database with new maintenance tracking system

Validation Specialist

● Wrote IQ/OQ/PQ for Datastream software for new CMMS program

● Wrote and executed protocols for temperature mapping on temperature controlled environment using KAYE Digistrip equipment and software

● Wrote and executed protocols for sterilization studies on autoclaves and dry heat ovens

● Wrote SOP’s for operation of validation equipment, field calibration on process equipment, and operation of calibration test equipment.

BERKS TECHNICAL INSTITUTE, Wyomissing, PA

1992 – 1993

Electronics Instructor

Taught all electronic courses in Computer Repair Technician Servicing Program. Prepared course outline and objectives for Electronics Degree Program.

JRH BIOSCIENCE, Denver, PA

1990 – 1993

Senior Quality Assurance Technician

Calibrated all instruments used in production and laboratory. Validated all sterility loads

for autoclaves and dry heat oven. Maintained all calibration and validation files. Performed daily environmental monitoring in Class 1000 clean room.

BARBEY ELECTRONICS, Reading, PA

1989 – 1990

Instrumentation Specialist

AT & T MICROELECTRONICS, Reading, PA

1988 – 1989

Process Analyst

EASTON HOSPITAL, Easton, PA 1982 – 1986

Biomedical Technician

Education

Indiana University of Pennsylvania, Indiana, PA

Bachelor of Science degree in Biology, minor in Chemistry

Penn State University, Wilkes-Barre, PA

Associates of Arts Degree, Bio-Medical Technology

Memberships/Certificates

ISPE Delaware Valley Chapter – member

PDA – member

Certificate from PDA for completion of Sterilization course and calibration course

Certificate from ISPE for Protocol Writing course

Certificate from Kaye for Temperature Validation course

Certificate from Validation Institute for Validating Utilities course

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