Engineer Medical Device
Resume:
SHAHLA SIPOURA ZAGHI
Sunnyvale, CA 94087
***********@*****.***
PROFILE
Validation Engineer with extensive experience in both pharmaceutical and
manufacturing industries using chromatography, spectroscopy and wet
chemistry techniques under cGMP guidelines. Exceptional team player with
strong communication skills and the ability to work well with all levels of
an organization.
SELECTED SKILLS
Software Programs Data Systems
Microsoft( Word Millennium 32 Waters
Microsoft Excel Empower, LIMS,
HP ChemStation
Instrumentation Laboratory Techniques
HPLC, GC Cleaning Validation of the Systems.
UV-Visible Spectrophotometer, FTIR Target preparation for DNA
Conductivity, Karl Fisher, DNA Scanner Sample Preparation
Tablet dissolution, TOC
Professional Experience
VALIDATION ENGINEER CONTRACT POSITION OCT2007-DEC2009
Abbott Vascular in Temecula, Bayer HealthCare's biotech in Emeryville and
AIC Labs, Alameda, CA
. Performed process validation activities including writing protocols &
reports, preparing master validation plans, addressing deviations and
utilizing advanced statistical process techniques.
. Wrote installation/operational and equipment performance qualification
protocols for Waters HPLC Systems.
. Prepared commissioning packages for the HPLC Systems.
. Executed supplemental installation and operational qualification for the
Waters HPLC Systems.
. Performed analytical testing of biomass by HPLC and GC.
Data Reviewer Contract Position Nov2006-Sep2007
Conor Med Systems, Menlo Park, CA
. Data Reviewer in Analytical Chemistry Department.
. Responsible for review and release of data packets for QC clinical lot
release, stability studies and other protocols according to Conor test
procedures for medical device.
Analytical Chemist Apr1995-Sep2006
Johnson and Johnson Corporation -Analytical Division, Mountain View, CA
. Performed analytical testing of drug substances and oral dosage
formulations using the following analytical test methods: residual
solvents, drug content, and release rate/dissolution.
. Investigated and troubleshot problems in instrument and sample analysis
as needed.
. Reviewed data and prepared lot history records of test results.
Participated in process improvements.
. Reviewed and released both internal and external QC test records.
. Conducted daily water testing for conductivity and total organic carbon
(TOC) analysis.
Education / Training / Awards
BS IN CHEMISTRY PAHLAVI UNIVERSITY, SHIRAZ, IRAN
Workshops and seminar training on HPLC instrumentation given by Waters
and HP Company and LIMS
Trained in "Interaction with the FDA"
Certified in ISO9001:2000 procedures
Completed coursework in "Fast and Effective Technical Writing"
Received Group Award for a tablet dissolution study of sustained release
tablets, which was performed in record time.
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