Computer System Validation Analyst

Foster City, CA, US • Posted 30+ days ago • Updated 1 hour ago

Full Time

On-site

Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

SCADA
Programmable Logic Controller
URS
DS
DirectShow
IQ
OQ
PQ
GxP
Computerized System Validation
GAMP
Verification And Validation
Change Management
Documentation
Process Control
Project Planning
Risk Assessment
Traceability Matrix
Standard Operating Procedure
Management
Reporting

Summary

Summary :

Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition
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.

Roles & 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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 6cb31b21252890c46e66d9855019ee55
Posted 30+ days ago

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Computer System Validation Analyst

Dice Job Match Score™

Job Details

Skills

Summary

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