US-CA-Palo Alto: Validation Engineer
http://sqa.fyicenter.com
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http://sqa.fyicenter.com/jobs/99681350_Validation_Engineer.html
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Date: 08-Sep-2008
Validation Engineer
The ideal candidate will have at least 7 years as a computer systems
validation engineer either at a software company or in a FDA regulated
company.
Job Description Summary
* Perform computer validation activities in support of the Quality
Service Organization * Develop validation plans/approach/policy *
Project Management/Execution of validation activities
Detailed
* Working with the client and our development team to develop
validation estimates, resource requirements and detailed project
plans. * Oversee the validation projects from needs analysis to go-
live. * Perform or review and approve computer validation activities
and other Quality Assurance activities. * 21 CFR Part 11 assessments/
remediation activities. * Defend Quality Assurance program during
external audits. * Requires experience generating/reviewing/approving
requirements and design specifications, and creating/executing/
approving test protocols (IQ/OQ/PQ). * Oversee adherence to Project
Management Office (PMO) delivery & risk mitigation standards. *
Develop a tight and concise communication plan. Manage the plan
especially with respect to issues and escalations. * Conduct customer
presentations around our validation products and services.
Job Qualifications
* A bachelor's degree in Information Systems or Sciences * PMI
certification desirable.
* Minimum of 7+ years working experience in a similar role for
software vendors or FDA regulated companies. * Experience managing
validation projects from a delivery perspective. * Knowledge of
Quality Management Systems in the FDA industry. * Strong Project
Management skills and experience * Oral communication skills that can
be universally described as eloquent, articulate and lucid. * Written
communication skills of publication-level quality (white papers,
blogs, etc.) * Excellent organization and interpersonal skills *
Ability to work with remote teams.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com