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Engineer Quality Assurance

Location:
Lafayette Hill, Pennsylvania, United States
Posted:
October 25, 2016

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Resume:

PROFESSIONAL PROFILE

Senior Validation Engineer (14 years) / background as Research Chemist (20 years), with validation management and quality compliance experience within the pharmaceutical, biotech, and medical device industries.

As a consultant Validation Engineer, acquired expertise in the areas of:

FDA Quality Systems Regulations

GxP (Good Manufacturing Practices / Good Laboratory Practices)

Title 21 Code of Federal Regulations (Parts 210/211, 11, 820)

ISO 9001/USP 1058 Quality System Standards.

Systems Development Life Cycle (SDLC) for computerized systems

Equipment and process validations

Project Management

Quality Compliance and Information Technology protocols and policies.

Developed and/or executed compliance documentation, including:

Computerized System Validation (CSV) Assessments

Gap Analyses / Risk Assessments (RA)

Master Validation Plans (MVP) / Compliance Plans (CP)

User Requirement Specifications (URS) / Functional Requirement Specifications (FRS)

Traceability Matrices (TM)

Test Protocols (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualifications (PQ), User Acceptance Tests (UAT) and Data Migration Tests (DM))

Test and Validation Summary Reports (VSR)

As a former full-time Research Chemist, acquired experience in the areas of:

Laboratory and manufacturing environments and protocols

Wide variety of computerized analytical instrumentation, equipment and software

Polymer Synthesis and Characterization

Formulation of new chemical substances and development of applications*

Analytical Chemistry and Instrumentation

Statistical Process Control (SPC)

Manufacturing Production Scale-up.

Patents awarded in recognition of applying highly creative problem-solving abilities to achieve business and scientific goals [Rohm and Haas].

PROFESSIONAL EXPERIENCE

VALIDATION

JANSSEN R&D US – JOHNSON & JOHNSON March 2014 – May 2016

Technical Writer III / Business Analyst Consulting Firm: Rose International

Malvern, PA August 2015 – May 2016

Lead Technical Writer/Validation Consultant for Pharmaceutical Research and Development Information Technology (Pharma R&D IT); with project goals of coordinating with internal business communities on validation and/or change control of various business applications.

Project Tasks:

Developed documentation (CP, URS, UAT, & DMT) for data migration of legacy storage to new cell line biorepository.

Developed documentation (CP, URS) for implementation of consolidated server supporting multiple GE Healthcare Avant Äkta protein separation instruments.

Developed documentation (CP, URS, IQ, DMP, & UAT) for the Chemical and Analytical Tracking System (CATS).

Developed documentation (URS) for Metalogix archiving solution.

Spring House, PA March 2015 – August 2015

Member of Technical Testing and Readiness Team (TT&R); governance team overseeing planning and execution of Systems’ and Integration testing on Planisware P5; the Project & Product Portfolio Management (PPM) software solution.

Project Tasks:

Instrumental in development of overall integration test strategy, including data and environment requirements, timeline, coordination with external teams, and phased implementation.

Created overall strategy document for integration testing requirements and activities.

Coordinated with external terms to ensure P5 system integrated into enterprise infrastructure and connected systems (i.e. payroll DB, resource DB, data warehouse, global connections, etc.)

Spring House, PA March 2014 – March 2015

Lead Technical Writer for JEDI Planning & Control workstream, Functional Planning group; with project goal of implementing enterprise-level planning/scheduling software solution. This application increased planning effectiveness and transparency, providing the ability to understand how the addition of a compound and its trials impacts all resource needs across Research &Development; repeating this process across various therapeutic areas and clinical phases. This enabled R&D to have improved process flow and adaptable tools to allow them to effectively allocate resources to activities needed to support the R&D business.

Project Tasks:

Technical consulting and GDP guidance on development of SDLC documentation for Planisware P5; an Enterprise Project & Product Portfolio Management (PPM) software solution which supported end-to-end governance of company portfolio planning.

Technical consulting and GDP guidance on development of SDLC documentation for User Community Tool (UCT); a separate in-house user-interface portal application allowing users to interface with the Planisware PPM software.

Development and administration of JIRA Tracking Tool for use in management of defect issues associated with development, testing and use phases of Planisware project implementation; Functional Planning/Align Project Structures [FPAPS].

GLAXO SMITHKLINE October 2012 – May 2013

King of Prussia, PA

Validation Engineer-Biopharmaceutical Research Consulting Firm: Valpro Resourcing Inc.

Validation Engineer; with responsibility for drafting and executing Word-based validation documentation for computerized biopharmaceutical instrumentation systems/equipment in accordance with GMP guidelines.

CSV included:

Agilent UV/VIS Spectrophotometers

Microplate Readers

Processed Change Control validations of Electronic Experiment (eE) laboratory templates employing Quality Center 10. Laboratory spreadsheet templates supported validation of:

Laboratory Information Management Systems (LIMS); specifically Computerized Laboratory Systems (CLS),

Electronic Laboratory Notebook (ELN)

Atomic Absorption (AA)

Size Exclusion Chromatography (SEC)

Capillary Isoelectric Focusing (cIEF)

Reverse Phase High Performance Liquid Chromatography (RP-HPLC)

IMAGING SCIENCES INTERNATIONAL January 2012 – April 2012

Hatfield, PA

Validation Engineer-Operations Consulting Firm: Liberty Personnel Services

Validation Lead orchestrating Operations Validation for a global leader in the development and manufacture of advanced dental and maxillofacial radiography medical devices. Managed process validation activities on Gendex/I-CAT panoramic dental systems and subassemblies, including x-ray tube head, sensor, and motor/electrical engineering functions. Addressed and managed all Change Control (Engineering Change Notice) procedures connected with assembly process parameters.

CORDIS – JOHNSON & JOHNSON April 2011 – December 2011

Spring House, PA

Validation Engineer I Consulting Firm: US Tech Solutions

Consultant to Johnson & Johnson’s Convergent Product Development group; responsible for complete SDLC validation of computerized analytical instrument systems related to quality control of coronary stent medical devices. Created validation documentation from preliminary assessment and planning phase, through test script development and execution, to summary reports. Involved with Change Control, data transfer, and decommissioning activities of both COTS and configured instrumentation and equipment.

CSV included:

Aspex eXplorer™ Personal Scanning Electron Microscope (PSEM)

Next Generation Coating Durability Tester(s)

Thermal Advantage Q5000 IR Thermogravimetric Analyzer (TGA)

MERCK ENVIRONMENTAL LABORATORIES September 2008 – January 2009

West Point, PA

Senior Validation Consultant Consulting Firm: Covex, LLC

Validation Team Leader; responsible for guiding the drafting and executing of validation documentation for pharmaceutical instrumentation systems in accordance with GMP/GLP guidelines. Developed Validation Package for networked system of Millipore Integritest ‘Bubble Testers’, consisting of Validation Plan (VP), Functional Requirements Specifications (FRS), Installation/Operational Qualifications (IO/OQ) Protocols and Reports, and Validation Summary Report (VSR). Assisted in execution of test qualifications, and interfaced with Quality Assurance department to address any issues involving validation of systems.

CSV included:

(6) integrated Millipore Integritest 4N Automatic Filter Integrity Test Instruments w/Central Instrument Management Tool software

CHEIL JEDANG PHARMA June 2008 – August 2008

South Korea

Senior Validation Consultant Consulting Firm: Covex, LLC

Business Analyst; responsible for evaluating and developing Quality Assurance processes, including creation of SOP infrastructure, Statistical Process Control (SPC), and Change Control development methods.

Comprehensive SOP infrastructure

ÉLAN DRUG TECHNOLOGIES August 2007 – May 2008

King of Prussia, PA

Senior Validation Consultant Consulting Firm: Covex, LLC

Responsible for drafting and executing validation documentation for biotech instrumentation systems in compliance with 21 CFR Part 11 requirements, and in accordance with GMP/GLP guidelines. Created Validation Package for analytical systems consisting of Computerized Systems Validation (CSV) Assessments, Validation Plan (VP), Requirements Specifications (RS), Installation/Operational Qualification (IOQ) Protocols and Reports, User Acceptance Test (UAT) Protocols and Reports, and Validation Summary Reports. Guided execution of test qualifications. Interfaced with Quality Assurance and Information Technology departments to address any issues involving validation of computerized instrument systems. Assisted Quality Assurance with internal and external audits, Corrective and Preventative Action (CAPA) remediation, and maintenance of electronic documentation databases.

CSV included:

Tekmar Dohrmann Phoenix 8000 TOC Analyzer w/associated TOC Talk application software

Horiba LA-910 Laser Scattering Particle Size distribution analyzer

Perkin Elmer Lambda 25/35/45 Spectrophotometer(s)

Electronic Document Management System (EDMS)

Waters Empower Chromatography Data System

CENTOCOR R&D – JOHNSON & JOHNSON September 2005 – April 2007

Great Valley, PA

Validation Consultant – Pharma R&D IM Consulting Firm: QA Edge, Inc.

Member of select interagency consulting team, responsible for drafting and executing validation documentation for pharmaceutical instrumentation systems in compliance with 21 CFR Part 11 requirements, and in accordance with GMP/GLP guidelines. Created Validation Package for analytical equipment consisting of CSV Assessments, VP, URS/FRS, IOQ and Reports, UAT and Reports and Validation Summary. Guided execution of test qualifications. Interfaced with QA and IT departments to address any issues involving validation of systems.

CSV included:

Applied Biosystems Procise Protein Sequencer

Bayer Diagnostics Rapidlab 248 pH/Blood Gas Analyzer

Beckman Coulter ProteomeLab PA 800 Capillary Electrophoresis Analyzer

Convergent Bioscience iCE280 cIEF Capillary Electrophoresis Analyzer

GE Healthcare ÄKTA™ Explorer Automated Liquid Chromatography System

Jasco J-810 Circular Dichroism Spectropolarimeter

Molecular Devices SPECTRAmaxÔ Plus384 Microplate Spectrophotometer

Perkin Elmer JANUS Automated Workstation

MERCK & CO, INC. (Recalled) February 2004 – July 2005

West Point, PA (Initial Phase) November 2002 – May 2003

Validation Specialist – MRL Drug Metabolism Consulting Firm: cGMP Validation LLC

Project Supervisor for Drug Metabolism; solely responsible for drafting and executing validation documentation for over (40) pharmaceutical instrumentation systems in Drug Metabolism in compliance with 21 CFR Part 11 requirements, and in accordance with GMP/GLP guidelines. Created Validation Package for analytical equipment consisting of VP, URS/FRS, IQ/OQ/PQ, UAT, and Summary Reports. Guided execution of test qualifications. Interfaced with QA and IT departments to address any issues involving validation of systems.

CSV included:

CyberLAB Information Retention System SOFTmax™ and SigmaPlot software

Dynex Luminometers SPECTRAmax™ Microplate

Lab-Line Humidity Chambers and Ovens Spectrofluorometers

Micromedic and Titertek Gamma Counters TECAN Robotic Sample Processors

Perkin Elmer 2000 Series FTIR Spectrometers ThermoFinnigan LCQ Mass Spectrometers

Perkin Elmer Sciex API Mass Spectrometers ThermoFinnigan TRACE GC/MS

Perkin Elmer Thermogravimetric Analyzers Varian Cary UV/Vis Spectrophotometers

PK/PD Modeling System software Wallac 1420 Multilabel Counters

QUADRA 96 and MultiPROBE Wallac 1450 MicroBeta® TriLux/JET Liquid

Liquid Sample Transfer Systems Scintillation and Luminescence Counters

MERCK & CO, INC. August 2003 – January 2004

West Point, PA

Validation Specialist – MMD Vaccine Automation Consulting Firm: cGMP Validation LLC

Validation Lead; responsible for several projects within Vaccine Automation Services. Drafted and executed validation documentation for pharmaceutical instrumentation systems in compliance with 21 CFR Part 11 requirements, and in accordance with GMP/GLP guidelines. Assisted QA and IT departments with reorganization and streamlining of Change Control records.

CSV included:

THERMOmax™ and VERSAmax™ Optical Density Plate Readers

ThermoONIX VG Prima dB Mass Spectrometer for fermentation unit

STRYKER BIOTECH June 2003 – July 2003

Hopkinton, MA

Validation Specialist Consulting Firm: cGMP Validation LLC

Responsible for drafting and executing validation documentation for biotech equipment systems in accordance with GMP/GLP guidelines. Created Validation Package for analytical systems consisting of CSV Assessments, VP, URS, IOQ protocols and reports, UAT protocols and reports, and Validation Summary. Assisted in execution of test qualifications. Interfaced with IT department to address any issues involving validation of systems.

Employed Kaye Validator 2000 Temperature Mapping Unit

MERCK & CO, INC. November 2002 – May 2003

West Point, PA

Validation Specialist – MRL Drug Metabolism Consulting Firm: cGMP Validation LLC

Member of initial staffing team for Validation Remediation Project on over 700 pharmaceutical instrumentation systems. Project halted in May 2003, and resumed in early 2004. Recalled as Supervisory Lead on Drug Metabolism division’s analytical systems. See above entry for more detail.

CHEMISTRY

ROHM AND HAAS COMPANY RESEARCH LABORATORIES 1991 – 2002

Spring House, PA

Analytical Chemist/Scientist – Analytical and Computational Technology (2000-2002)

Primary responsibility for analyses by X-ray Diffraction (XRD) using a Philips XRG 8100; investigating crystal phase structure and distribution within powdered samples.

Supporting responsibility for analyses by X-ray Fluorescence (XRF) techniques and instrumentation.

Auxiliary responsibility as global contact for elemental analyses using automated potentiometric techniques, including methods for determination of acid content and distribution, hydroxyl number, and moisture content via Karl Fischer.

Streamlined processes for XRD/XRF analyses, resulting in a reduction of turn-around time for data delivery from 1-2 weeks to 1-2 days.

Designed and developed database process for the tracking and prioritization of submitted work requests, resulting in improved accountability and data retrieval.

Developed a familiar knowledge of auxiliary methods of analyses, including Inductively-Coupled Plasma Atomic Fluorescence Spectroscopy (ICP), Electron Spectroscopy for Chemical Applications (ESCA), Differential Scanning Calorimetry (DSC), and Time-of-flight Secondary Ion Mass Spectroscopy (TOF-SIMS).

Analytical Chemist/Scientist – Colloid Support Team /Analytical Research (1998-2000)

Technical scientist member of a multi-disciplinary in-house analytical team formed to problem-solve immediate technological dilemmas involving colloidal systems. Investigated molecular physical properties of colloidal systems application to future polymer synthesis design.

Successfully employed technique of automated capillary viscometry (CV) to determine micelle hydrodynamic radius (particle size) and Huggins constants, useful in characterizing colloidal properties.

Patent pending on utilization of sonication techniques in the separation of colloidal systems, which reduced waste treatment/recycling time in customer account.

Intricately involved with designing and balancing monophobe-diphobe ratio in latex system in order to exponentially improve paint viscosity and durability.

Synthesis Chemist/Scientist – Formulation Chemicals (1993-1998)

Responsible for the design, synthesis and characterization of solution and emulsion polymerizations. Polymers were formulated into products for use in household laundry detergent (HHLD), automatic dishwasher detergent (ADD), and ceramic binder (CER) applications.

Performed polymer characterizations via HPLC, GPC, and GC.

Patents Issued:

No. 5,730,760: Fabric Washing Composition and Method for Inhibiting Deposition of Dye. Granted March 24, 1998.

No. 5,843,192: Washing Composition and Use of Polymer to Clean and Provide Soil Resistance to an Article. Granted December 1, 1998.

No. 5,858,944: Polycarboxylates for Automatic Dishwashing Detergents. Granted January 12, 1999.

Synthesis Technician – Formulation Chemicals (1991-1993)

Responsible for the synthesis and characterization of aqueous solution polymerizations. Member of Project Management team with responsibility for interfacing with Applications and Scale-up scientists, as well as Manufacturing and Marketing Department representatives.

Instrumental in forwarding synthesis program of biodegradable polymers to be formulated into household laundry detergents.

Optimized process using poly(succinimide) / poly(aspartic acid) chemistry for this purpose, resulting in several company patents issued.

Developed knowledge and skills in Design of Experiment techniques (DOE).

Enhanced computer skills, including Excel, Word, and PowerPoint.

QUAKER CHEMICAL CORPORATION 1985 – 1991

Conshohocken, PA

Formulation Chemical Technologist – Metalworking Division

Formulated soluble oil industrial lubricants for use in coolant systems for the manufacture of iron and steel parts for the automotive industry; and aluminum and tin-plate can manufacture for the beverage industry.

Utilized soluble oil/solution synthetic emulsion chemistry and tribology to design new products and modify existing lubricants.

Gained experience with use of analytical techniques, including IR and UV.

Developed and applied knowledge of Statistical Process Control (SPC).

Traveled extensively to customer sites and gained field experience troubleshooting account coolant systems.

SADTLER RESEARCH LABORATORIES 1982 – 1985

Philadelphia, PA

NMR Technician Specialist – Spectra Lab

Responsible for the preparation and analysis of experimental and commercial chemicals using a Varian CFT-20 Nuclear Magnetic Resonance Spectrometer (NMR). Additionally operated Digilab IR and Beckman UV spectrophotometers.

EDUCATION

Cabrini College, Radnor, PA 1991

Bachelor of Science, Chemistry

Villanova University, Villanova, PA 1981

Bachelor of Science, General Program (BSG), Pre-Med Curriculum

Minor degree in Psychology.

Related Course Work::

Animal Physiology

Biochemistry

Genetics

Microbiology

Molecular Biology

Physiological Psychology

Technical Writing

PROFESSIONAL CERTIFICATIONS

21 CFR Part 11 Electronic Records / Signature Rule Training March 18, 2003.

Good Laboratory Practice Regulations 21 CFR Part 58 Training January 22, 2003.

GMP Training: CFR Title 21 – Parts 210-211 November 2002.



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