Sr. Computer Systems Validation Engineer Job Foster City area,California USA,Engineering

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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