Quality & Validation Engineer
Engaged in Quality / Compliance with 23 years as a quality & validation engineer assuming responsibilities in the FDA / EMEA regulated Biotech industries (i.e. Pharma 21CFR Part 211 and ASTM E2500, Class 2A/2B/3 Medical Devices 21CFR Part 820 and ISO 13485, IVD’s 98/79/EC) as QE lead/supervisor, Quality assurance specialist, Quality control specialist and Business analyst.
20 years of experience authoring, revising, approving, executing and reporting validation protocols for Computerized Systems (development / manufacturing), Equipment, Process, Facility/Utility, Test Methods, and Cleaning.
18 years of experience developing 21CFR Part 11 & Annex 11 (ERES) relevant SDLC documentation and deliverables per ISPE GAMP5 Waterfall and Agile / SCRUM methodology.
Skilled with First Article Inspections, DOE’s, feasibility studies, system suitability, engineering studies, applying 6sigma, SPC, SQC, TQM and performing gage R&R / TMV’s.
Skilled at investigating IR, DR, OOS, OOT and conducting audits, gap assessments, CAPA and resolving findings using risk management tools including IEC 60812.
Experienced in managing projects, assessments, detailed & executive summaries and developing project charters, master validation plans, progress metrics, data analysis, final reports and recommendations.
Experienced in team building, consulting, and training with respect to validation methodology, compliance, industry standards, regulations, and quality engineering.
Responsible for project budgeting, hiring / training employees, resolving issues / conflicts, prioritizing project items / resources based on risk & effectiveness and keeping a dynamic project based on regulatory/management needs.
My efforts were instrumental in bringing Teva Parenteral systems, equipment and processes into compliant validated stated with respect to GxP relevant computerized systems. With team's effort, helped in lifting Teva's consent decree after subsequent successful FDA audits.
As a team member, during Covidien's acquisition of a startup medical device manufacturer, was a key asset in the successful transition and production/tech-transfer.
Was successful in identifying and rectifying gross and fundamental regulatory/compliance issues with PMS, AE, and MDR reporting/trending and resolved discrepancies/inaccuracies within systems and processes.
Developed $10Million 3-tier GxP remediation Project for South Korea’s LG LS facility (via Management Services International).
Software: MS Office (Access, Excel, Word, Power Point, Outlook, Project, Visio), MiniTab, Statgraphics / Centurion, Statistica, BM CalMAN, GAGEtrak, Trackwise, SQL Server Mgmt Studio, CATsWeb, Quality Center v10, Test Director, LabView, AMMS, Agile, Documentum, Kaye Validator and Digistrip thermal mapping.
Systems: SAP R/3 v4.7 & SAP EP7 ERP6.0:2013 (modules: MM, SD, PP, FICO, LO, CS, PL, WM&RF), MfgPRO, Oracle ERP/PLM systems, Solidworks ERP module, Wonderware, Allen Bradley, Lighthouse, Camstar MES, Siemens & Allen Bradley PLC’s.
CDS/SDMS/LIMS: Waters Millennium and Empower v3, Masslynx, Chemstation, Chromeleon v6.8-7, Waters ELN, Labware LIMS and NuGenesis.
Databases: SQL, Oracle, MS Access, and JIRA.
Other Standards: 21CFR Part 58 (GLP), ANSI/ASQC Z1.4/Z1.9, ICH guidelines, EMEA GMP – 91/412/EEC & 91/356/EE, ISO 9001/2/3, ISO 14644, EN45001 / ISO 17025, IEC 62304 / IEC 12207 / IEC 15288, 60601-1, ISO 14971, EN 61010, ISO 14001, ASME Y14.5 (GD&T).
Client : Illumina (San Diego, CA)
Role : Sr. Validation Engineer
Dates : 10/2016 – present
In the area of DNA and genomic sequencing technology: authoring, executing, reviewing, and approving: TMV’s, IOPQ’s (EQ’s) on production QC systems / instruments (e.g. HPLC, RI, Viscometer, Nikon Vision systems, etc), DOE’s, feasibility / engineering / system suitability studies.
Performing risk assessments / FMEA on software & computerized systems (e.g. MES, LIMS, robotic systems, microplate reader, etc).
Authoring, executing, reviewing, and approving SDLC documents including URS, SRS, FRS, SDD, VMP, VP, V&V, IOQ’s test scripts, integration testing, UAT, VSR.
Client : Calhoun Vision (RxSight) (Aliso Viejo, CA)
Role : Facility Utility Validation specialist
Dates : 10/2015 – 06/2016
Generated Site Master Validation Plan.
Assisted in development & reviewing mechanical, electrical, plumbing, cleanroom, process gases, architectural, IT Infrastructure, ESD and EH&S design specifications against facility layouts / plans. Provided instructions for corrections and as-is verification.
Generated / executed facility, utility and equipment validation documentation.
Supported EH&S, Cal / Fed OSHA, and OCFA activities.
Client : Irvine Pharmaceutical Services Nitto Avecia (Irvine, CA)
Role : CSV specialist
Dates : 03/2014 – 09/2015
Developed procedure for Data Migration (including table reconfiguration to VMware servers) and Archiving protocols with test scripts for LIMS system.
Assessed and performed 21 CFR Part 11 (ERES) / GAMP5 compliance gap audit of Computerized Systems, mainly Chromatography and general Lab Systems: (e.g. TGA, DSC, TOC, HPLC, GC, LIMS, etc) which include software such as Dionex Chromeleon, Zetasizer, Agilent/Varian.
Generated gap / audit reports and plans.
Generated relevant documentation to remediate gaps with respect to ERES regulations and GAMP5 standards.
Consulted / advised on strategies to mitigate non-compliance.
Administered / modified system settings to comply with ERES.
Generated Remediation Plan / Documents.
With the expertise of Technical Owner, SME administered / modified system security and audit trail settings.
Generated SDLC relevant documents, per GAMP5 and ERES.
Trained employees with respect to ERES and GAMP.
Client : Covidien Medtronic (Irvine, CA)
Role : Quality Engineer Product Transfer Lead
Dates : 09/2014 – 12/2014
Directed a team of quality engineers in product integration project.
Generated Quality and Process / Equipment / Design Validation procedures / procedures / policies.
Generated dFMEcA and pFMEcA for stent product of an acquired stent manufacturer, “Reverse Medical”.
Performed gap analysis of current manufacturing and design/process against DS, clinical data, and DHF documentation. This included generation of remediation plan for quality relevant documentation, dimensional and functional testing.
Improved and created inspection points / test methods.
Reviewed / commented on QP and MP SOP’s and trained QEs and MEs on proper drafting of documents.
Generated Gage R&R and Test Method Validations.
Trained engineers and generated various tool / test fixture Feasibility, Engineering, and DOE studies.
Improved and implemented compliance to an existing process.
Migrated and implemented a fully manual process into semi-automated operation.
Developed a training program for operators, inspectors, and QC leads / supervisors.
Client : Siemens Healthcare (Newark, DE)
Role : Equipment Validation Engineer
Dates : 08/2014 - 09/2014
Authored IOQ and PQ protocols / test cases for Korsch and Stokes tablet presses and granulators controlled by Allen Bradley PLC, Wonderware SCADA / HMI interface.
Developing and performing Process Characterization protocols for tableting process.
Client : Abbott Medical Optics J&J (Santa Ana, CA)
Role : Validation Engineer
Dates : 01/2013 – 08/2013
Generated compliance gap assessment on process, CatsWeb SQL database and SAP per FDA and other global governing agencies (EMEA, HCan, CFDA, CDSCO, MHLW, TGA, MHRA), local site, AMO global, and divisional policies and regulations with respect to product safety & compliance metrics (i.e. Post Market Surveillance, Adverse Events, MDR, monthly, quarterly, and annual regulatory agency submission).
Generated detailed compliance and technical assessment, reports, and executive summary to management.
Created 21 CFR Part 820 / ISO 13485 (GxP), 21 CFR Part 11 / Annex 11 (electronic records and electronic signatures or ERES) compliance gap remediation plans and risk assessment, which included implementation and integration with existing technology (i.e. SAP Business Intelligence / Business Objects and Web Client).
Revised / created procedures and validation SOP’s to comply with divisional policy and GxP / ERES.
Revised existing process and validation SOP’s to comply with GxP, ERES, global, divisional policy.
Generated technical Work Instructions (WI) for Adverse Event (AE), MDR, quarterly and annual product safety / complaints trending and data acquisition process between CatsWeb and SAP.
Performed gap analysis, generated a remediation report, and Validation Protocols for PMS (post market surveillance), AE, MDR, and Complaints Tracking spreadsheets.
Generated VMP, Risk Assessment, URS, DS, FS, IOQ (including test cases), Trace Matrix, and Summary Report for complaints trending and process capability study spreadsheets.
Tracked and reported on progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.
Managed activities to resolve project issues with team members and project stakeholders: subject matter experts (SME’s), Business Owners (BO’s), and Technical Owners (TO’s).
Authored / executed validation and verification documentation, GAMP5 SDLC documentation and reported on activities / deliverables pertaining to product trending systems/processes.
Trained team on strategies for improved trending accuracy between CATSWeb and SAP.
Various Projects with Teva Parental Medicines (Irvine, CA), 2010 –2012
Role : Computer System Validation Specialist
Dates : 08/2012 – 12/2012
Authored Requirement Specifications (i.e. URS, FS, SDS) and Test Scripts for Waters ELN Forms in Quality Center v10 (QC) and resolved associated deviations in QC and TKS.
Authored associated SDLC documentation: Validation Master Plan (VMP) and Validation Summary Report (VSR).
Trained technical owners on GxP / ERES requirements and testing scripts.
Role : Quality Systems Engineer
Dates : 04/2011 – 06/2012
Maintained and assured compliance of current / new Computerized & Automated Systems, per local / global policies, SOP’s, regulatory agencies:
Assured the compliance of businesses, functional and user requirements with respect to system, procedural, interface, data, business, and regulatory requirements (please see note at end of this section for detailed list.)
Reviewed, trained on, and approved SDLC deliverables such as VMP, User Requirement Specifications (URS), Functional Design Specifications (FDS), Design Specifications (DS), Software Design Specifications (SDS), Hardware Design Specifications (HDS), IQ / OQ (including UAT, Integration, functional testing) / PQ, vendor audits, Trace Matrix (TM), Summary Report (VSR), Risk Analysis (RA), and Administration / Use/ Maintenance & Periodic Review SOP’s.
Cultivated communicative rapport with management and executives across QC / R&D Laboratories, RA, IT Compliance, Engineering, Operations / Mfg, Facilities, Maintenance and Metrology (local site and global).
Ensured the completion and approval of the Software Development Life Cycle phases (SDLC) deliverables for all departments (as stated above), the validation status, approval for system release with respect to implementation and maintained compliance of the system’s validated state after release.
Led meetings to provide QA SME guidance with respect to site, global, and regulations.
Identified and resolved issues by employing criticality, risk / severity analysis, and regulatory / business requirements.
Documented activities issues, severity, risk/severity, and provided progress / issues / action plan reports to upper management.
Trained users and stakeholders (spc. BO’s and TO’s) on GAMP process, procedural and site / global policies, change control, spreadsheet validation requirements, authoring of SDLC documentation, etc.
Developed, revised, edited, and implemented validation policies and SOP’s (ERES, Lab Systems, and Equipment Engineering Controls) pertaining to Lab System Assays / Methods, Change Control, System Administration, Maintenance, and Calibration.
Additional responsibilities consist of:
Supported validation of product, equipment and process as it relates to review of data, and analysis. Supported data collection, analysis and reporting to identify and then optimize the most important parameters affecting product quality and support implementation of CAPA and Root Cause Analysis (RCA) as it relates to DR, complaints, IR, observations and OOS.
Revised / approved Admin, Use, Method, Assay, Instrument, and contingent SDLC SOP / WI’s.
Supported Internal / External Regulatory Audits as a Computerized System QA SME.
Supported internal and agency audits and inspections of computerized systems.
Addressed, reported and mitigated observations identified during these events.
Generate remediation plans as needed.
Reviewed, commented, and approved Change Requests in TrackWise for Critical & Non-critical System Change Requests within Engineering Controls, Lab, and Enterprise Systems.
Role : Computerized Systems Validation Specialist
Dates : 07/2010 to 04/2011
Authored Laboratory Systems / Instruments and Engineering Controls SDLC documents (VMP, FDS, URS, SCS, IQ, OQ, PQ, TM, VSR, Admin SOP, Change Management documents) and executed test scripts.
Performed periodic review (PR) of software / system, ERES assessments and generated reports (4).
Revised and assisted in creation of SOPs with respect to Use, Administration, and Maintenance.
*Partial list of systems remediated / validated:
(1)Spreadsheets, LabWare LIMS, Empower 2, Agilent Chemstore / Chemstation / Kiosk, NuGenesis, Vitek, Chromeleon Dionex, Nicolet, Avatar, Lonza, Solaar, Waters ELN, Coulter, Tiamo, and Malvern, Leica Mic, IC, AA ThermoScientific, Turbisoft / Turbiscan, GC/MS, UV-Vis, and LC.
(2)TOC, cPMS, Honeywell Chart Recorders (MiniTrend controllers) with TrendManager SCADA System, Allen Bradley based BMS / SCADA, and PLC’s / PID’s: HVAC, Fillers, Isolators, Lyophilizers, Autoclaves, Homogenizers, Vision Systems, and gas distribution systems.
(3)BM Calman, WM Ware, CommVault, Trackwise, TevaDoc ‘Documentum based’, and Oracle based ERP/systems.
(4)Technical reviews and audits performed on: LIMS, LS, ELN, Empower, FirstDoc, Chemstation, AA, GC, LC, DSC/TGA, Turbidity, Particle sizers, BM-CalMan, TOC, Instron, Vitek, NuGenesis.
Client : Boston Scientific Neuromodulation (Valencia, CA)
Role : IS Validation Engineer
Dates : 03/2010 – 07/2010
Procured documentation while performing software / system assessments, ERES review, Baseline, and Intended Use.
As part of the remediation process, prepared / augmented / edited any documentation needed as part of gap analysis (such as Design, User, System Req. Specs, IQ, Test Scripts, SOP’s, Manuals, and Trace Matrixes).
Procured Retirement Plans, data migrations, and disposition of software and hardware.
Reported on the above mentioned.
Prepared project plans and projected resource needs.
Client : WaveTec Vision Alcon Novartis (Aliso Viejo, CA)
Role : Facility & Utility Validation and V&V specialist
From : 04/2008 – 02/2009
Authored and executed V&V validation protocol/report, GUI/Integration test scripts.
Developed test and trace matrix for the Intra-Optical and Aberrometer device.
Performed Facility & Process Validation (IOQ document development and execution).
Client : Amgen Small Molecule (Thousand Oaks, CA)
Role : Business Analyst
Dates : 12/2007 – 03/2008
Created Quality Department’s Project Plan and Resource Predictor Model for product life cycle: pre-clinical, Phase 1/ 2/ 3, regulatory filing, commercial and contract manufacturing.
Defined structure and business needs.
Provided suggestions on quality resources and budget requirements.
Organized meetings and review with executives/stakeholders, gaps / inconsistencies within resourcing and budgeting.
Client : Applied Medical (Irvine, CA)
Role : SAP Validation Engineer
Dates : 02/2006 – 12/2008
Developed SDLC documentation for validation of SAP modules in CA, Europe, and Australia.
Developed all GAMP required SDLC documentation for validation of SAP modules in CA, Europe, and Australia.
Development of blueprints, landscape design, technical architecture, system requirements specifications, functional design specifications, risk analysis, traceability matrix, unit/integration test scripts and other supporting documentation.
Trained team on GMP/GDP/ISO/QSR/EMEA regulatory needs and validation process.
Validated the WM-RF Barcoding, FICO, MM, PP, SD, CO, and FI modules.
Consulted and audited WLAN, RF site survey and stress testing scripts, execution and reports.
Developed, maintained, and tracked validation deliverables.
Client : Edwards Life Science (Irvine, CA)
Role : Alternate Material Quality Engineer
Dates : 06/2007 – 09/2007
Note: Many of Edward's components, raw material, and textile vendor sites were ending contracts with Edwards, ceased to produce the materials needed, or were needed for new devices.
Reviewed / commented / approved: FMEA’s, specifications, drawings, protocols and data submitted to FDA, corporate, site, and ASTM/ANSI compliance.
Generated reports and remediation action items based on gaps / deviations.
Performed statistical analysis on data gathered by field CQA's and Quality team members.
Reviewed for compliance and adherance to FDA regulations / standards and device requirement specifications:
oStatistical analyses protocols
oTest Methods used and TMV's
Provided guidance / training based on statistical analysis, FMEA, sampling plan, and compliance to regulations / standards.
Convened in daily update meetings providing project status, milestones accomplishments, deliverables, and present bottlenecks with proposed resolution.
Advised management / team on contingency and backup plans to keep in compliance with challenging vendors, suppliers, manufacturers.
Various Projects with Intralase Abbott Medical Optics J&J (Irvine, CA), 2000-2006
Role : Validation Specialist Quality Engineer Project Manager
Dates : 11/2000 – 12/2006 and 08/2006 – 12/ 2006
Executed QNX embedded software GUI test scripts on the FS Laser system.
Documented deviation observations, resolved / mitigated, and re-executed.
Authored / executed assembly equipment (e.g. cone adhesive system), facility / utility, and process validations.
Executed equipment, test methods and ERES compliance audit.
Prepared safety, chemical storage, and industrial hygiene assessments / reports.
Role : Quality Engineer Validation Specialist
Dates : 11/2000 - 12/2003 and 01/2005 to 07/2005
Authored / executed assembly equipment (e.g. IOQ/PQ cone adhesive system), facility / utility, and process validations.
Executed equipment, test methods and ERES compliance audit.
Prepared safety, chemical storage, and industrial hygiene assessments / reports.
Client : Dendreon, Seattle, WA
Role : Quality Engineer Associate Biostatistician
Dates : 05/2005 – 06/2006
Developed statistical method / plan, performed statistical analysis, DOE, sample size and number of runs determination, and established efficacy acceptance criteria for Provenge vaccine Process Validation and manufacturing capability.
Evaluated statistical data to make determination regarding molecular, cellular, and protein efficacy & potency data for IND and NDA submission to the FDA which resulted in a successful approval.
Developed cleaning validation method for Commercial Immunotherapy Manufacturing Facilities.
Developed Risk Analysis and pFMEA for systems, documentation and manufacturing processes.
Supported Biostatistics department with respect to clinical studies in SAS.
Provided general statistical training to Quality Assurance members.
FOR BREVITY EARLY CAREER DETAILS SPANNING BACK TO 1995 WILL BE PROVIDED UPON REQUEST.
Seminars / Workshops / Presentations Provided:
“IQ, OQ, PQ in the Verification and Validation Process” - Presenting for several institutions, 2017
“The Top Method Validation Mistakes – And How to Avoid Them” - Presenting for several institutions, 2017
“Facility & Utility Validations: Complying with FDA regulations – Theoretical vs. Actual Approach” –Presenting several learning institutions, 2016
“Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance” - Presenting for several institutions, 2016
“21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s” – Presenting for several institutions, 2016
“Auditing of Micro QC Lab” and “Validation of Laboratory Equipment in an FDA Regulated Environment” – AulaGMP, Barcelona Spain, 2003
“Developing an effective CAPA system” workshop – Intl Qual & Productivity Ctr. (IQPC), Coronado CA, 2002
“Validation of Laboratory Instruments” and “Auditing the QC Microbiology Lab” - Pharmaceutical Training Inst. (PTI), Princeton NJ / Philadelphia PA / Boston MA, 2001
Formal Degree: University of California at Irvine (1995)
B.S. - Biological Sciences (emphasis: chemical engineering and microbiology)
A.S. – Psychology
Irvine Valley College: Network Administration and front/back end web design.
Institute of Validation Tech: 21 CFR Part11 compliance, validations, qualifications
Agile Scrum Master Principles