Gary Shifflett is a highly qualified expert, who works in Gilead Sciences on the position of Senior Validation Specialist from 2016. This person gained professional experience in more than 37 positions at various companies. Nashville, Tennessee is the city, where this expert was known to be living. This professional's contacts are accessed through Connexy on demand.
Name variants:
Garrett Shifflett
Contact Information
Last Update
Jul 9, 2022
Email
ga**@validation.org, gw**@gmail.com, gs**@validation.org
Location
Nashville, TN
Company
Workplace
Senior Validation Specialist
San Mateo, CA
Industry
Biotechnology, Mfg Biological Products, Pediatrician, Internist, Pharmaceutical Preparation Manufacturing, Biological Product (except Diagnostic) Manufacturing
Colleagues
Work History
Senior Validation Specialist
Currently providing validation support for a new manufacturing facility.
Mar 2016 — Sep 2019
Senior Validation Specialist
Joined the existing VTI teams to assist in the qualification efforts for the Genzyme Facilities and Equipment upgrade project. Responsibilities included the development / execute and report ...
Jul 2015 — Jan 2016
Vti Project Lead and Senior Validation Specialist
Providing Validation support for ImmunoGen Inc. cGMP Pilot Plant
Developed and executed Installation / Operational Qualification protocols for the following systems:
CO2 Incubators
Huber...
Oct 2011 — Jun 2015
Vti Project Lead and Senior Validation Specialist
Developed Performance Qualification for a Fedigari waste autoclave. Developed Validation protocol for Sterile Hold Times on Process Equipment sterilized by the cGMP Autoclave. Developed an S...
Jul 2011 — Oct 2011
Vti Project Lead and Senior Validation Specialist
Managed a small team of validation personnel in the developed process validation protocols for Hold time and mixing studies for reagents, buffers, intermediate products, produced in INOVA’s ...
Jan 2011 — Jun 2011
Vti Project Lead and Senior Validation Specialist
Developed and executed Installation / Operational Qualification protocols for a -80°C Revco Freezer, a 4°C to 8°C walk in cold room with a connected -20°C Freezer. Validation process include...
Jun 2011 — Jun 2011
Vti Project Lead and Senior Validation Specialist
Developed and executed a liquid nitrogen freezer protocol. Validation process included temperature mapping the unit with a Kaye Validatior 2000 data acquisition test instrument. This short p...
May 2011 — May 2011
Vti Project Manager, Asia
Provided execution direction to local Chinese technical operators on Cycle Development and PQ studies for Fedegari Dry Heat Oven & Steam Autoclave.
Nov 2010 — Dec 2010
Vti Project Manager, Asia
Project Managed the Process Validation for the transfer of manufacturing process to CDIBP’s new Japanese Encephalitis (JE) vaccine manufacturing facility. Developed and executed IOQ & PQ’s f...
Oct 2009 — Oct 2010
Vti Project Manager, Asia
Managed a team of Validation Engineers in the Qualification of newly constructed ISO 8 and ISO 9 Cleanrooms and supporting utilities. Assisted and train individuals on equipment used to test...
Apr 2009 — Oct 2009
Vti Project Lead and Senior Validation Specialist
Lead and supported qualification activities for a $70 million biomedical manufacturing facility build out. Project scope included integration of central plant BMS and HVAC systems servicing ...
Jan 2009 — Apr 2009
Vti Senior Validation Specialist
Joined the VTI team already on site to support the validation project. Activates included temperature mapping of multiple incubators and cold rooms using the Kaye Validator 2000.
Jul 2008 — Dec 2008
Vti Project Lead and Senior Validation Specialist
Project scope included integration of central plant utilities and HVAC systems into redesigned production clean rooms. Worked directly with the commissioning authority and assisted in the de...
Mar 2005 — Apr 2007
Vti Project Lead and Senior Validation Specialist
Activities included writing and executing IQ and OQ protocols for the qualification of analytical instruments, equipment, and utilities for the Quality Analytical Laboratories.
Nov 2004 — Jan 2005
Vti Project Lead and Senior Validation Specialist
Activities included managing, writing and executing IQ, OQ and PQ protocols for the qualification of an RO water system, Clean Steam system, Cryogenic Freezers, Dry Heat Oven, and four cGMP ...
Apr 2003 — Nov 2004
Vti Project Lead and Senior Validation Specialist
Activities included writing and executing HVAC System Performance Qualifications for environmental controlled areas servicing 100,000, 10,000, and 100 Class Clean Room Areas. Additional qual...
Jun 2001 — Dec 2001
Vti Senior Validation Specialist
Activities included writing and executing IQ, OQ and PQ protocols for the qualification of HVAC systems and environmental control systems servicing 1K, 10K, and 100K class clean room areas. ...
Jan 2001 — Mar 2001
Vti Senior Validation Specialist
Activities included writing and executing OQ and PQ protocols for the qualification of steam sterilizers and dry heat ovens. Execution included setup and running of Kaye equipment for empty ...
Feb 2000 — Apr 2000
Vti Senior Validation Specialist
Activities included writing and executing protocols for computer controlled process systems. These systems include Cell Processing Vessels, multiple Centrifuges and Chromatography Skids, and...
Jan 1999 — Jan 2000
Vti Senior Validation Specialist
Activities included writing and executing protocols for utility systems, which included RO/DI, WFI, Process Gases, and Clean Steam. Additional development included Process equipment required...
1998 — 1999
Vti Senior Validation Specialist
Activities included writing and executing protocols for temperature and humidity controlled stability chambers. Additional responsibilities included final report writing.
1997 — 1998
Vti Validation Specialist
Prepared IQ and OQ protocols for a 650L Bioreactor.
1997 — 1997
Vti Validation Specialist
Prepared and executed IQ and OQ protocols for deionized water and pure steam utilities and component preparation autoclave. Preparation of operation and maintenance Standard Operating Proced...
1997 — 1997
Vti Senior Validation Specialist
Analytical instrument software qualification that included execution of IQ and OQ protocols. Instruments included atomic absorbtion spectrophotometers and ion chromatography systems.
1997 — 1997
Vti Corporate Associate and Validation Manager
VTI offers a full spectrum of services such as computer validation, cleaning validation, process validation, clean room certification, temperature mapping, process equipment and facility qua...
from Jun 1996
Vsi Validation Specialist
Prepared and executed qualification protocols for clean room HVAC systems, Clean Steam, process gases, low temperature chillers, architecture and finishes, sanitary piping, Cold Rooms, Proce...
1995 — 1996
Vsi Validation Specialist
Prepared and executed qualification protocols for cleanroom HVAC systems, Clean Steam, process gases, low temperature chillers, architecture and finishes, sanitary piping, Cold Rooms, Proces...
1994 — 1995
Fluor Daniel Validation Specialist
Prepared and executed qualification protocols for an autoclave and the CIP and Steam-In-Place of various size tanks and their transfer lines.
1993 — 1994
Fluor Daniel Validation Specialist
Prepared and executed qualification protocols for the plant steam system, Castle Autoclave, Pharmetics Waste Autoclave, and the Nitrogen System. Also, assisted with the validation of the con...
1993 — 1993
Fluor Daniel Validation Specialist
Prepared and executed OQ and PQ protocols for the facilities Clean-in-Place and Steam-in-Place systems within the media preparation area of an international pharmaceutical manufacturer's bio...
1992 — 1993
Fluor Daniel Validation Specialist
Prepared Standard Operating Procedures for the facility utility systems.
1993 — 1993
Fluor Daniel Validation Specialist
Prepared and executed IQ and OQ protocols for a Process Research Facility that included 78 systems used for bulk pharmaceutical manufacturing.
1992 — 1992
Fluor Daniel Validation Technician
Assisted in the execution of IQ and OQ protocols for the HVAC, chilled water, dust collection, emergency power, and instrument air systems.
1991 — 1991
Fluor Daniel Validation Technician
Assisted in the preparation and execution of IQ, OQ and PQ protocols for a Finn-Aqua Autoclave. Developed load configurations and cycle times for multiple loads.
1990 — 1990
Alcon Senior Quality Assurance Auditor
Performed scheduled audits to ensure manufacturing and QA processes were in conformance with established specifications and in compliance with FDA Good Manufacturing Practice requirements. R...
Jun 1984 — Dec 1989
Communications Repair Specialist
Performed the duties required of a United States Army Solider. Responsibilities included trouble-shooting and repair of electronic communications equipment, both in the field and shop enviro...
Jul 1980 — Jul 1984
Occupations
Supporting Member
Executive
Manager
Sales Specialist
Equipment Tools Purchasing Agent
Team Member
Operations Manager
Department Store Salesperson
Retail Salesperson
Skills
Validation
21 Cfr Part 11
V&V
Gmp
Cleaning Validation
Fda
Computer System Validation
Sop
Change Control
Capa
Gxp
Gamp
FAQs about Gary Shifflett
What's the main profession of Gary Shifflett?
Gary is a Vti Corporate Associate and Validation Manager.
What are the main profession of Gary Shifflett?
These person's professions are Supporting Member
Where does Gary Shifflett currently live?
Gary lives in Nashville, Tennessee.
Does Gary Shifflett have the email address?
ga**@validation.org and gw**@gmail.com is Gary's email address.
Where did Gary Shifflett work?
The expert worked at Gilead Sciences, Sanofi Genzyme.
What is professional industry that Gary Shifflett is connected to?
This professional works in Pharmaceuticals industry.
What are the skills of Gary Shifflett?
Gary has skills in the following areas: Validation, 21 Cfr Part 11, V&V, Gmp, Cleaning Validation, Fda, Computer System Validation, Sop, Change Control, Capa, Gxp, and Gamp.