CSV Engineer

Bothell, WA - USA

Monthly Salary: Not Disclosed

Posted on: 06-11-2025

Vacancies: 1 Vacancy

Job Summary

Position: CSV Engineer (MES - Manufacturing Execution System experience must)

Location: Bothell WA(On-site Role)

Job Description

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

Note: Momento USA is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex pregnancy sexual orientation gender identity national origin age protected veteran status or disability status.

Position: CSV Engineer (MES - Manufacturing Execution System experience must) Location: Bothell WA(On-site Role) Job Description Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test...