Sr. Computer Systems Validation Analyst

Roles & 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.

• 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

Katalyst Health Cares & Life Sciences