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Sr. Computer Systems Validation Analyst

Katalyst Healthcares and Lifesciences

Foster City, California • Today

Full-time

Computer Systems Validation Engineer

Praxis Precision Medicines

Remote • Today

Full-time

USD 150,000.00 - 178,000.00 per year

Senior Software Systems Engineer, Autonomous Systems Validation Confidence

General Motors

Remote or Sunnyvale, California • Today

Full-time

USD 153,200.00 - 234,100.00 per year

Sr. Systems Validation Engineer

SUPERMICRO COMPUTER INC

San Jose, California • Today

Full-time

USD 130,000.00 - 165,000.00 per year

Workday Sr Systems Analyst

Shriners Hospitals for Children

Remote • Today

Full-time

Senior Verification & Validation (V&V) Engineer

SysMind, LLC

Milpitas, California • 5d ago

Easy Apply

Contract, Third Party

$48 - $52

Senior System Validation Engineer

OSI Engineering, Inc.

Hybrid in Sunnyvale, California • 17d ago

Easy Apply

Contract

Depends on Experience

Senior Verification & Validation (V&V) Engineer

TechClub Inc.

Milpitas, California • 2d ago

Easy Apply

Contract

50 - 55

CSV (Computer System Validation) Lead

NexInfo Solutions, Inc.

Remote • 2d ago

Easy Apply

Contract, Third Party

80 - 85

CSA Consultant/Senior Validation Engineer 2

Clevanoo LLC

Remote • 6d ago

Easy Apply

Contract

Depends on Experience

Sr Engineer Software Validation

Medline Industries, LP

Remote • Today

Full-time

USD 101,000.00 - 152,000.00 per year

Sr. Business Systems Analyst - Validation (CSA) Governance & Process Support

Arthrex

Remote • Today

Full-time

To define

Sr Engineer, Silicon Validation

Ayar Labs

San Jose, California • Today

Full-time

Senior System Level Verification Engineer

Axiado

San Jose, California • Today

Full-time

Senior Virtual Platform Functional Modeling Engineer

AMD (Advanced Micro Devices)

Remote or Austin, Texas • Today

Full-time

USD 156,100.00 per year

Senior DSP SW Engineer

E-Space

Santa Clara, California • Today

Full-time

USD 140,000.00 - 200,000.00 per year

Systems Analyst III

CareSource

Remote or Dayton, Ohio • Today

Full-time

USD 94,100.00 - 164,800.00 per year

System Modeling Engineer

AMD (Advanced Micro Devices)

Santa Clara, California • Today

Full-time

USD 119,000.00 per year

Senior DevOps Validation Engineer

Keeper Security, Inc.

Remote • Today

Full-time

Principal DSP SW Engineer

E-Space

Santa Clara, California • Today

Full-time

USD 140,000.00 - 200,000.00 per year

Advanced Power Integrity & Power Delivery Architect

Rivian

Palo Alto, California • Today

Full-time

USD 186,000.00 - 296,000.00 per year

Sr Mgr Validation Engineering

Rambus

San Jose, California • Today

Full-time

USD 161,700.00 - 300,300.00 per year

Senior Manager, Engineering - AI Validation

Sonatus

Sunnyvale, California • Today

Full-time

USD 240,000.00 - 290,000.00 per year

Principal Engineer, Digital Verification and Emulation

Ayar Labs

San Jose, California • Today

Full-time

USD 190,000.00 - 250,000.00 per year

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

Senior Validation Engineer

AstraZeneca

Redwood City, California • Today

Full-time

USD 101,643.20 - 152,464.80 per year

Senior Engineer, GPU Graphic Core Performance Verification

Samsung Electronics America

San Jose, California • Today

Full-time

USD 124,000.00 - 208,400.00 per year

Senior Hardware Validation Engineer

Wing

Palo Alto, California • Today

Full-time

USD 211,000.00 - 224,000.00 per year

Senior Director System Validation Engineer

Astera Labs

San Jose, California • Today

Full-time

USD 240,000.00 per year

Senior SoC Verification/Validation Engineer

Astera Labs

San Jose, California • Today

Full-time

USD 165,000.00 per year

Job Details

Skills

Process Control
URS
DS
DirectShow
Risk Assessment
Traceability Matrix
IQ
OQ
PQ
Regulatory Compliance
Collaboration
Quality Assurance
Computerized System Validation
Life Sciences
Pharmaceutics
SCADA
Programmable Logic Controller
GAMP
Change Control
Management
GxP
Manufacturing
Technical Writing
Documentation
Communication
Project Coordination

Summary

Summary :
We are seeking a Senior Computer Systems Validation (CSV) Analyst with strong experience in GxP-regulated pharmaceutical/life sciences environments. The candidate will be responsible for planning, leading, and executing validation activities for SCADA, Rockwell FactoryTalk, PLCs, and Ignition process control systems.
The role requires hands-on expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, validation lifecycle documentation, risk assessments, change controls, and qualification protocols (IQ/OQ/PQ). The candidate will work closely with engineering, automation, quality, IT, and business teams to ensure systems remain compliant and validated.

Roles & Responsibilities :

Plan, lead, and execute CSV activities for SCADA, PLC, Rockwell FactoryTalk, and Ignition systems.
Develop and review URS, FS, DS, Validation Plans, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Summary Reports.
Author and maintain documentation for GxP computerized systems.
Apply GAMP 5 principles throughout the computer system validation lifecycle.
Execute software/system validation test protocols and document results.
Manage change controls for existing qualified systems.
Assess system changes and determine validation impact.
Prepare/revise validation documentation based on system changes.
Ensure compliance with 21 CFR Part 11 and EU Annex 11.
Manage deviations, issues, CAPAs, and validation discrepancies.
Develop and execute test protocols and maintain proper evidence/documentation.
Maintain project schedules and ensure validation deliverables are completed on time.
Collaborate with Automation, Engineering, QA, IT, Manufacturing, and business stakeholders.

Education & Experience :

5+ years of experience in Computer Systems Validation (CSV) within Life Sciences/Pharmaceutical/Biotech environments.
Strong experience validating SCADA, PLC, Rockwell FactoryTalk, and/or Ignition systems.
Hands-on experience with GAMP 5 and risk-based validation approaches.
Strong knowledge of 21 CFR Part 11 and EU Annex 11.
Experience with change control and system requalification.
Experience managing deviations, issues, CAPAs, and corrective actions.
Strong understanding of GxP computerized systems and regulated manufacturing environments.
Excellent technical writing and documentation skills.
Strong communication and project coordination skills.

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: f122cd717d0f231b4f6161a38a6a3425
Posted 30+ days ago

Fitment

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Job Details

Skills

Process Control
URS
DS
DirectShow
Risk Assessment
Traceability Matrix
IQ
OQ
PQ
Regulatory Compliance
Collaboration
Quality Assurance
Computerized System Validation
Life Sciences
Pharmaceutics
SCADA
Programmable Logic Controller
GAMP
Change Control
Management
GxP
Manufacturing
Technical Writing
Documentation
Communication
Project Coordination

Summary

Plan, lead, and execute CSV activities for SCADA, PLC, Rockwell FactoryTalk, and Ignition systems.
Develop and review URS, FS, DS, Validation Plans, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Summary Reports.
Author and maintain documentation for GxP computerized systems.
Apply GAMP 5 principles throughout the computer system validation lifecycle.
Execute software/system validation test protocols and document results.
Manage change controls for existing qualified systems.
Assess system changes and determine validation impact.
Prepare/revise validation documentation based on system changes.
Ensure compliance with 21 CFR Part 11 and EU Annex 11.
Manage deviations, issues, CAPAs, and validation discrepancies.
Develop and execute test protocols and maintain proper evidence/documentation.
Maintain project schedules and ensure validation deliverables are completed on time.
Collaborate with Automation, Engineering, QA, IT, Manufacturing, and business stakeholders.

Education & Experience :

5+ years of experience in Computer Systems Validation (CSV) within Life Sciences/Pharmaceutical/Biotech environments.
Strong experience validating SCADA, PLC, Rockwell FactoryTalk, and/or Ignition systems.
Hands-on experience with GAMP 5 and risk-based validation approaches.
Strong knowledge of 21 CFR Part 11 and EU Annex 11.
Experience with change control and system requalification.
Experience managing deviations, issues, CAPAs, and corrective actions.
Strong understanding of GxP computerized systems and regulated manufacturing environments.
Excellent technical writing and documentation skills.
Strong communication and project coordination skills.

Dice Id: 91116760
Position Id: f122cd717d0f231b4f6161a38a6a3425
Posted 30+ days ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

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