Sr. Computer Systems Validation Analyst

Title: Sr. Computer Systems Validation Analyst Location: Foster City, CA - OnsiteDuration: Long TermPay Rate: $50-$56/hr on W2

Plan, lead, and execute the validation efforts for SCADA, Rockwell FactoryTalk, PLCs, 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.

Deliverables: 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

Benefits: This a contract position does not include employer-provided benefits.Equal Opportunity Employer: We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.Background Check: Background checks may be conducted in accordance with applicable law.Work Authorization: Applicants must be authorized to work in the United States