Job Description
Summary:
Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
You should have excellent understanding of CFR Part , ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions Exception reports which identify defects or issues during test execution Review vendor documentation.
MES expertise is must
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Job Details
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Location
Bothell, Washington
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Job Type
Full-time
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Category
Computer Occupations
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Posted Date
June 07, 2026
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Application Deadline
July 17, 2026