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Sr. CSV Engineer (MES - Manufacturing Execution System) _ Bothell, WA ( onsite)

Bothell, WA, US • Posted 1 day ago • Updated 1 day ago

Contract Independent

Contract W2

Contract Corp To Corp

On-site

Depends on Experience

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Job Details

Skills

21 CFR Part 11
GMP
GxP
FDA
MES
CSV
Validation

Summary

Requirement details:

Job Title: Sr. CSV Engineer (MES - Manufacturing Execution System experience must)

Location: Bothell, WA ( onsite)

Duration : 12+ Months

Job Description:

10+ Years of IT Experience

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 21 CFR Part 11, 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

Resource has to work from Bothell location

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91085654
Position Id: 8807268
Posted 1 day ago

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