Validation Engineer

GUOBIN WU

***** ** **** ***** ** APT **, Portland, OR 97***

Tel: 503-***-**** Email: ********@*******.***

OBJECTIVE

Validation Engineer position in pharmaceutical or medical device industries

EXPERIENCE

QA Manager, Canadian Custom Packaging Company, Toronto, ON, Feb 2009 – Aug 2010

- Managed Master Validation Plan and supervised QA department

- Designed equipment qualification protocols for tanks, filling and packaging machines

- Scheduled process validation and re-validation for new and existing drug processes

- Wrote cleaning validation protocols to verify the effectiveness of each cleaning method

- Developed and validation analytical methods for cleaning validation (LOQ<10ppm)

- Successfully validated the storage tank systems as planed budget and timeline

- Conducted temperature and humidity mapping study for stability chamber

- Studied temperature excursion effect on products by calculating warehouse KMT

- Used t-test, SPC, AQL, DOE, regression, trend analysis, HACCP and 6-SIGMA tools

- Initiated cost reduction projects to save up to 60% cost on stability testing

- Responsible for change control, vendor qualification, deviation and custom complaint

- Successfully passed cGMP, ISO9001, ISO13485 and third-party audits

- Supported R&D, production, regulatory affair, purchasing and planning departments

- Worked as a leading role in cost reduction and PIP programs

QC Chemist, Ascendia Brand Canada Inc., Scarborough, ON, 2005 – 2008

- Wrote IQ, OQ and PQ protocols

- Conducted process validation for drug products

- Conducted cleaning validation for premise and equipments

- Validated mixing tank content uniformity and process capability

- Performed chemical and microbiological testing as per USP methods

- Maintained, calibrated and operated HPLC, GC, UV-VIS, FT-IR and KF

- Developed and validated analytical methods

- Participated in GMP audit and third party audits

R&D Associate, State Key Laboratory of Chemical Engineering, Shanghai, 2000 – 2003

- Assisted senior scientists in research and development of drug intermediates

- Searched literatures and wrote protocols for synthesis routines and analytical methods

- Developed and validated analytical method for assays using GC/MS, UV and HPLC

- Set up, calibrated and troubleshot laboratory instruments

- Analyzed data and developed mathematical models

EDUCTION

ASQ Certified Quality Engineer (CQE), 2007

Toronto Institute of Pharmaceutical Technology, Toronto, ON, 2004 - 2005

Post-Graduated Diploma in Pharmaceutical Quality Assurance and Quality Control

East China University of Science and Technology, China, 1990 - 2000

B. Sc. (1994), M. Sc. (1997), Ph. D. (2000) in Chemical Engineering

Equivalency Assessed by WES & FIS

REFERENCES Provided upon request

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