Ecocareers ยท 3 weeks ago
Sr. Computer Systems Validation Analyst
Foster City, CA
Full-time
Onsite
Senior LevelEcocareers is a company looking for a Senior Computer Systems Validation Analyst. The role involves planning, leading, and executing validation efforts for various control systems, as well as creating and authoring necessary validation documentation and managing change for existing qualified systems.
Staffing & Recruiting
Responsibilities
Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Talk
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
Qualification
Required
Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Talk
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