Ecocareers ยท 1 month ago
Computer System Validation Analyst
Foster City, CA
Full-time
Onsite
Mid LevelConfidential company is seeking a Computer System Validation Analyst to plan, lead, and execute validation efforts for various process control systems. The role involves creating validation documentation, executing test protocols, and managing change for existing qualified systems.
Staffing & Recruiting
Responsibilities
User and Configuration Specifications
System Impact Assessments
Risk Assessments
Installation Qualification Protocols
Operation Qualification Protocols
Performance Qualification Protocols
Traceability Matrix
Summary Reports Standard Operating Procedures
Authoring Change Controls
Authoring and executing test protocols
Managing Issue Reporting, Deviations and related CAPAs
Qualification
Required
Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition
Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems
Author documents related to GxP Systems
Draft Requirements and computer systems validation documents using GAMP 5
Execute test protocols for the software validation
Initiate and execute change management for existing qualified systems
Develop change management record, create or revise documentation if required, and execute implementation tasks
Use understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to a process control system
Maintaining the project plan/schedule to meet deliverable commitments
User and Configuration Specifications
System Impact Assessments
Risk Assessments
Installation Qualification Protocols
Operation Qualification Protocols
Performance Qualification Protocols
Traceability Matrix
Summary Reports Standard Operating Procedures
Authoring Change Controls
Authoring and executing test protocols
Managing Issue Reporting, Deviations and related CAPAs
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