Sr. Computer Systems Validation Engineer

Sr. Computer Systems Validation Engineer Apply for the Sr. Computer Systems Validation Engineer role at Katalyst CRO.

Summary

Plan, lead, and execute validation efforts for SCADA, Rockwell Factory Talk, PLCs, and Ignition Talk.

Develop, author, and maintain validation documentation for GxP systems using GAMP 5 (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ).

Execute test protocols for software validation.

Initiate and manage change control for existing qualified systems, creating records, revising documentation, and executing implementation tasks.

Apply understanding of 21 CFR Part 11 and Annex 11 as they relate to process control systems.

Maintain project plans/schedules to meet deliverables.

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

Education & Experience

Minimum 5 years of experience required.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Quality Assurance

Industries: Biotechnology Research and Civil Engineering

Foster City, CA

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