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US-CA-Palo Alto: Validation Engineer
To see other opportunities,
please visit http://sqa.fyicenter.com
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.
For more information, please write to us.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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