Sr. CSV Engineer

Oregon City, CA, US • Posted 60+ days ago • Updated 10 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

GMP
GxP
GAMP
URS
Design Review
Computerized System Validation
IQ
OQ
PQ
Test Execution
Documentation
MES
Document Review
System Implementation
Acceptance Testing
Scripting
Risk Assessment
Application Lifecycle Management
Test Plans
Traceability Matrix
Reporting

Summary

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 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

Roles & 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

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: 91116760
Position Id: d51132e868e6d54b9150023a02e3453e
Posted 30+ days ago

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