Title: Sr. Computer Systems Validation Analyst
Location: Foster City, CA - Onsite
Duration: Long Term
Pay 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