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Pharma Tek Solutions

Senior Validation Engineer — 21 CFR, GAMP5, IQ/OQ/PQ

Pharma Tek Solutions, San Ramon, California, United States, 94583

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No of Positions: Multiple

Location: San Ramon, CA and various unanticipated locations throughout the U.S.

Job Description: Design, develop and oversee validation components and ensure compliance with 21 CFR Part 11, and Part 8, and GAMP5 regulations. Author and review Validation plan and Validation Summary reports. Track and manage defects and change controls using HP Quality Center, ALM and similar tools. Write and execute IQ/OQ/PQ scripts for functional, system, and regression testing. Performing Periodic and Audit Trail reviews.

Qualification: Master’s degree in Science, Technology, or Engineering (any) is required.

If interested, please send resume to HR Dept., Pharma Tek Solutions, Inc., 6101 Bollinger Canyon Road, Suite 336, San Ramon, CA 94583.

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