Experience

Mesa Biotech, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Sr Validation Engineer

  • Apr 2021 - Present



Fujifilm Life Sciences

• United States
• Biotechnology
• 1 - 100 Employee

• Process Engineer

  • Aug 2019 - Jul 2020

  cleaning validation, equipment validation project management cleaning validation, equipment validation project management



Archer (part of Integrated DNA Technologies)

• United States
• Biotechnology Research
• 1 - 100 Employee

• Process Validation Engineer

  • Oct 2018 - Mar 2019



Cook Medical

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Sr Validation Engineer

  • Jan 2018 - Oct 2018



Scientific Protein Laboratories LLC

• Waunakee, WI

• Sr Validation Consultant

  • Jan 2017 - Dec 2017



Grifols

• Spain
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Validation

  • Sep 2016 - Dec 2016



VTi Consulting

• United States
• IT Services and IT Consulting
• 1 - 100 Employee

• Sr Quality / Validation Engineer

  • Dec 2015 - May 2016



Ethicon

• Texas

• Sr Compliance Consultant

  • Aug 2015 - Nov 2015

  Revise manufacturing procedure, create new batch records to include 21CFR 820 and Part 4 requirements. Revise manufacturing procedure, create new batch records to include 21CFR 820 and Part 4 requirements.



Vention Medical

• Costa Rica

• Senior QA Engineer

  • May 2015 - Jun 2015

  QA Eng for plastic molding. Revised procedures, wrote OQ protocols for new products and equipment. Reviewed batch records, Minitab analyses. QA Eng for plastic molding. Revised procedures, wrote OQ protocols for new products and equipment. Reviewed batch records, Minitab analyses.



Baxter

• Medina, New York

• Quality Engineer

  • Jun 2014 - Dec 2014



Depuy Synthes

• West Chester, PA

• Validation Engineer

  • Jun 2013 - Apr 2014

  Remediation Remediation



Alere, Inc.

• San Diego

• Validation Consultant

  • Jan 2013 - Apr 2013

  Validation of multiple purified water systems. Validation of multiple purified water systems.



Merck

• Elkton. VA

• Sr Consultant

  • Feb 2012 - Jul 2012

  Develop all the Batch Records for Buffer and Media Prep and Hold/Fermentation/Harvest/Refold/AEX/Digest/CEX/HHPLC/ UFDF/Crystallization/Filter Dry for a newly developed product line. Develop all the Batch Records for Buffer and Media Prep and Hold/Fermentation/Harvest/Refold/AEX/Digest/CEX/HHPLC/ UFDF/Crystallization/Filter Dry for a newly developed product line.



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Consultant

  • Mar 2011 - Dec 2011

  Develop HVAC and BMS IQ and OQ protocols. Develop HVAC and BMS IQ and OQ protocols.



St Jude Medical

• Validation Engieer

  • 2010 - 2010

  Create new parent SOP and template chart for Process Control Plan to monitor existing validated systems. Create new parent SOP and template chart for Process Control Plan to monitor existing validated systems.



Spectranetics

• United States
• Medical Device
• 100 - 200 Employee

• Validation Engineer

  • Sep 2008 - Aug 2009

  Facility Validation for purified water system (RO & DI) to include: Write/execute IQs, OQs, PQs, Requirement specifications, Project Validation Plan, Requirement Trace Matrix, Protocol Deviation, Final Reports Revise pFMEA for Purified Water System, Redline P&IDs of purified water system Write SOPs for Microbial sampling and Use of alternate USP grade water supply; revise mfg SOPs. Audit and correct previous Utility Validation packages: Compressed Air, Cleanroom Qualification, Utility and Facility Validation Master Plan Write IQ and Operational SOP for facility Particle Monitoring System (LASAIR II / 510A) Write initial Change Control procedure Equipment experience: water softener system, Reverse Osmosis skid, filters, conductivity and pressure sensors, microprocessor controllers, TOC reduction unit, Ionization tanks, UV disinfection unit, TOC unit, Conductivity/Resistivity meter, Silica analyzer, particle monitoring system (controller, manifold, vacuum pump, controlling software) Show less



Novartis and Bayer

• Somerville, CA

• Validation Engineer

  • Apr 2007 - Jul 2008

  Equipment Validation for computerized laboratory systems to include: Write/execute IQs, OQs, PQs, Requirement specifications, Validation Plans, Requirement Trace Matrix, Protocol Deviations, Final Reports, change control execution plans Equipment experience: Applied Biosystems Protein sequencer, Applied Biosystems DNA analyzer, Hitachi Amino Acid analyzer, ProGroup Automated propettes, Hitachi imaged Capillary Isoelectric Focusing (cIEF) Equipment Validation for computerized laboratory systems to include: Write/execute IQs, OQs, PQs, Requirement specifications, Validation Plans, Requirement Trace Matrix, Protocol Deviations, Final Reports, change control execution plans Equipment experience: Applied Biosystems Protein sequencer, Applied Biosystems DNA analyzer, Hitachi Amino Acid analyzer, ProGroup Automated propettes, Hitachi imaged Capillary Isoelectric Focusing (cIEF)



Boston Scientific

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Validation Engineer

  • Jun 2006 - Mar 2007

  Process Validation for catheter line to include: Write/execute IQs, OQs, PQs, Attribute Test Method Validations, Reports Develop and implement process improvements (additional control tests, re-organize line flow) Revise pFMEA, process flowchart, MVP, Manufacturing Work Instructions Minitab analyses Equipment experience: Pulse Echo, Leak test (air, water), hot boxes, laser micrometers, Transducer manufacturing and testing, electrical continuity testing, tensile testing, dispensers, UV cure equip Show less



InBios International

• Medical Equipment Manufacturing
• 100 - 200 Employee

• Validation Engineer

  • Sep 2005 - Feb 2006

  Provide thermal/gas mapping studies of Finn Aqua autoclave (Load studies). Automated Vialer machine: IQ/OQ development and testing, Vision system, smoke test (UAF), component configuration testing Innova 4000 Incubator/shaker: time, temperature, and RPM Microbial Analyzer: SMA-CC-10: 10 atrium locations from one control center. Equipment experience: automated vialer, large depyrogenation oven, Finn-Aqua autoclave, continuous particle monitoring system, incubator/shaker Provide thermal/gas mapping studies of Finn Aqua autoclave (Load studies). Automated Vialer machine: IQ/OQ development and testing, Vision system, smoke test (UAF), component configuration testing Innova 4000 Incubator/shaker: time, temperature, and RPM Microbial Analyzer: SMA-CC-10: 10 atrium locations from one control center. Equipment experience: automated vialer, large depyrogenation oven, Finn-Aqua autoclave, continuous particle monitoring system, incubator/shaker



VaxGen Corporation

• Greater Los Angeles Area

• Validation Engineer

  • May 2005 - Aug 2005

  Provide thermal/gas mapping studies of CO2 incubators, refrigerators, and freezers Utilize 7 Kaye mapping systems simultaneously for validation of approximately 30 pieces of equipment. Maintain status reports; analyze data for spreadsheets and graphs. Package preparation and protocol executions. Equipment experience: refrigerators, freezers, CO2 incubators, thermal validation systems, LN2 cryogenic freezer (Validator 2000, IRTDs, thermocouples) Provide thermal/gas mapping studies of CO2 incubators, refrigerators, and freezers Utilize 7 Kaye mapping systems simultaneously for validation of approximately 30 pieces of equipment. Maintain status reports; analyze data for spreadsheets and graphs. Package preparation and protocol executions. Equipment experience: refrigerators, freezers, CO2 incubators, thermal validation systems, LN2 cryogenic freezer (Validator 2000, IRTDs, thermocouples)



Pfizer Corporation

• Chesterfield, MO

• Validation Engineer

  • Nov 2004 - Apr 2005

  Prepare protocols and change controls for multiple product lines in a pilot plant Execute protocols/reports for Network Control System in Manufacturing cleanrooms Review and Redline P&ID drawings Equipment experience: Wave® Bio-Reactors, CIP systems, SIP systems, Network Control System (NCS) CO2 incubators, Tubing welder and sealer, 100L, 250L, and 500L portable tanks Prepare protocols and change controls for multiple product lines in a pilot plant Execute protocols/reports for Network Control System in Manufacturing cleanrooms Review and Redline P&ID drawings Equipment experience: Wave® Bio-Reactors, CIP systems, SIP systems, Network Control System (NCS) CO2 incubators, Tubing welder and sealer, 100L, 250L, and 500L portable tanks



DPC

• Medical Equipment Manufacturing
• 100 - 200 Employee

• Validation Engineer

  • Sep 2004 - Nov 2004

  Provide thermal/gas mapping studies of CO2 incubators, waterbaths, refrigerators, and freezers Utilize 9 Kaye mapping systems simultaneously for validation of approximately 40 pieces of equipment. Maintain status reports; analyze data for spreadsheets and graphs. Supervise several contractors for validation package preparation and protocol executions. Equipment experience: refrigerators, freezers, CO2 incubators, waterbaths, centrifuges, wave reactors, thermal validation systems (Validator 2000, IRTDs). Employee: Gen-Probe Inc. Show less



Hologic (Formerly Gen-Probe)

• United States
• Biotechnology Research
• 300 - 400 Employee

• Validation Specialist

  • 2000 - 2004

  Conducting assessments of Validation requirements and procedures to ensure compliance with FDA guidelines, QA, Regulatory, QSRs and SOPs. Assisting with development and implementation of validation programs. Accomplished high throughput of equipment validations, qualifications, and re-validations to expedite FDA approvals. Developed working knowledge of Validation System (Kaye 2000) and associated temperature distribution equipment (CTR-80, LTR-140, smartprobes, Kaye Digistrip and KL models) for ~500 temperature distribution studies. Organized extensive validation packages including charts, graphs, inserts and spreadsheets, statistical analyses with EXCEL, North Western Analytical software. Responsible for maintaining the Validation Assessment Database and performing 95% of all equipment periodic validation assessments (approx. 400 pieces of equipment). Write technical reviews/investigation summaries, SOPs, batch records, change control protocols/reports, IQ/OQ/PQ protocols and reports. Show less



Dura Pharmaceutical, Inc

• Employee

  • Nov 1996 - May 2000

  Developed quality assurance and regulatory approved strategies for products and compliance with FDA regulations by: Reformulated drug products for robust and stable products required for FDA approvals Wrote and implemented protocols and technical reports for process development Created and maintained extensive databases identifying raw materials, in-process testing results and release testing of finished products Revised vacuum metered mass method for accurate dose weights within powder storage system Expedite product production for FDA approvals Equipment experience: Equipment to include Water Systems-WFI, HVAC utilities, Computers, mixers, blenders, stability rooms, dry powder filling line equipment, jet micronizer, photographic equipment Show less



Alliance Pharmaceutical, Inc

• Employee

  • Sep 1995 - Aug 1996

  Set-up and operation of manufacturing equipment for R&D and clinical production batches Prepared intermediate packaging materials (sterilized vials and stoppers) Assisted in inspection, labeling, and review of documentation of finished product Equipment experience: Equipment to include Water Systems-WFI, HVAC utilities, Computers, spray dryer, mixers, stability rooms, liquid powder filling line equipment, steam sterilizer, homogenizer, depyrogenation oven, stopper washer, stopper assembly Show less



Analytical Technologies, Inc

• Employee

  • Nov 1994 - Aug 1995

  Identified organic volatiles from soil and water samples Preparation of buffers, standards and solutions required for sample analysis Monitor supplies for expirations, FIFO, and quality of standards Run samples on GC and GCMS for peak identification. Identified organic volatiles from soil and water samples Preparation of buffers, standards and solutions required for sample analysis Monitor supplies for expirations, FIFO, and quality of standards Run samples on GC and GCMS for peak identification.