Ecocareers · 2 months ago
CSV Engineer
Bothell, WA
Full-time
Onsite
Mid LevelConfidential company is seeking a CSV Engineer responsible for preparing and executing test documentation for GMP computerized systems. The role involves troubleshooting issues during test execution and coordinating with a multi-disciplinary validation team to ensure compliance with regulatory 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
Required
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), 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
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
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase