Sr. CSV Engineer jobs in United States
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Ecocareers ยท 1 month ago

Sr. CSV Engineer

positionOregon City, CA
timeFull-time
remoteOnsite
senioritySenior Level

Confidential company is seeking a Sr. CSV Engineer responsible for preparing and executing test documentation for GMP computerized systems and supporting troubleshooting during test execution. The role involves coordinating with a multi-disciplinary validation team and creating validation documentation to ensure compliance with regulatory and client requirements.

Staffing & Recruiting

Responsibilities

Requirement Specification document review and approvals
System Implementation Plan Review
System Implementation Summary Report Review
Review and Pre-Approve ST/UAT Test Scripts in ALM
Create, Update RRA (Regulatory Risk Assessment) and obtain approvals
Post Execution Review and Post Approvals in ALM
CR Implementation Approvals
Retirement Plan Review
Retirement Summary review Deliverables: Requirement document
Validation/Test Plan
Requirement Traceability Matrix
Change Requests
Impact assessment document
Test/Validation Summary Report

Qualification

GMP regulations21 CFR Part 11GxP regulationsMES expertiseGAMP methodologiesValidation documentationTest documentationTroubleshootingMulti-disciplinary coordination

Required

Excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies
Coordinate with multi-disciplinary validation team
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)
Create reports which summarize the results of the protocol executions
Create exception reports which identify defects or issues during test execution
Review vendor documentation
MES expertise is must
Resource has to work from Bothell location
Requirement Specification document review and approvals
System Implementation Plan Review
System Implementation Summary Report Review
Review and Pre-Approve ST/UAT Test Scripts in ALM
Create, Update RRA (Regulatory Risk Assessment) and obtain approvals
Post Execution Review and Post Approvals in ALM
CR Implementation Approvals
Retirement Plan Review
Retirement Summary review Deliverables: Requirement document, Validation/Test Plan, Requirement Traceability Matrix, Change Requests, Impact assessment document, Test/Validation Summary Report

Company

Ecocareers

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Ecocareers provides a specialized job search for careers that make a difference.
location
Bristol, GB
people-size2-10 employees
web-link
https://ecocareers.org

Funding

Current Stage
Early Stage
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