Computer Software Validation Engineer

Title: Computer Software Validation Engineer
Location: Oakbrook, PA
Description:
Duration: Long Term
Due By: Immediate
Start: First week of Jan-13

Note: Skills highlighted are must, Must have FDA CFR 21 Part 11 experience. Most people who do this come from Baxter, Abbott or P&G etc.

Required:
* Expertise in FDA CFR 21 Part 11
* Strong knowledge of GAMP 4/5
* Must possess 7-10 years of experience in Part 11 computer software validation in a GMP environment
○ Expertise in COTS validation is a must
○ Expertise in custom and hybrid validation is also required
* Must have held at least one position where she or he was either the sole validation engineer or led a team validation effort
* Must have previously recommended and written a master validation plan
* Expertise in assessment of and writing of standard operating procedures pertaining to Part 11 in a GMP environment within both Quality and IT
* Must have prior validation experience with laboratory instruments (e.g. HPLCs, FTIRs, ...)
* Familiarity with the following is a plus:
○ Perkin Elmer Informatics
○ Quality software management systems such as Master Control, AsssurX, etc.
* Bachelor's degree at minimum
* Extremely strong written skillset
* Strong oral communication skillset

Pay Rate: DOE
Skills: FDA CFR 21 Part 11, GAMP 4/5, COTS validation

Notes: Only US Citizens, CG Holders or EAD's ready to take contract to hire
Excellent communication skills are required

Company: Not mentioned
Contact person: Santhosh
Contact information: santhosh@atsiweb.com