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Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Bothell, Washington • Today

Full-time

Principal Firmware Validation Engineer

Microsoft Corporation

Redmond, Washington • Today

Full-time

USD 142,800.00 - 274,800.00 per year

System Test and Validation Lead

Deloitte

Remote or Atlanta, Georgia • Yesterday

Full-time

USD 95,000.00 - 145,000.00 per year

Senior Deep Learning Engineer (Computer vision)

TechVirtue LLC

Remote • 2d ago

Easy Apply

Contract

$60 - $65

Post-Silicon Systems Software Validation Engineer

Arrow Electronics, Inc.

Remote or California • Today

Full-time

USD 87,400.00 - 165,000.00 per year

Staff Systems Engineer - Release Strategy & Validation

Torc Robotics

Remote or Ann Arbor, Michigan • Today

Full-time

USD 168,800.00 - 202,600.00 per year

Integration Validation Engineer- VHA Finance

HigherEchelon

Remote • Today

Full-time

Computer Aided Engineer

General Motors

Remote or Warren, Michigan • Today

Full-time

Data Validation Engineer

GlobalLogic Inc.

Remote • 18d ago

Easy Apply

Full-time

100000 - 110000

Sr. System Test Engineer - HiL

Torc Robotics

Remote or Ann Arbor, Michigan • Today

Full-time

USD 139,000.00 - 166,800.00 per year

Controls Engineer, Distributed Control System (DCS)

NAES

Remote or McKittrick, California • Today

Full-time

USD 140,000.00 - 165,000.00 per year

Sr. Software Engineer (Avionics)

Apex Bridge Talent Group INC

Lynnwood, Washington • 10d ago

Easy Apply

Full-time

Depends on Experience

Senior Device Validation Engineer

Flock Safety

Remote or Atlanta, Georgia • Today

Full-time

USD 150,000.00 - 190,000.00 per year

Engineer Pharma Validation

Medline Industries, LP

Remote • Today

Full-time

USD 73,000.00 - 110,000.00 per year

CSV Engineer

Katalyst Healthcares and Lifesciences

Seattle, Washington • Today

Full-time

System Engineer II (Cloud)

Accuity

Remote • Today

Full-time

USD 95,000.00 - 125,000.00 per year

AI Cluster Validation Architect

AMD (Advanced Micro Devices)

Seattle, Washington • Today

Full-time

USD 210,000.00 per year

Data System Engineer III

Franciscan Health

Remote • Today

Full-time

USD 82,931.74 - 114,031.14 per year

Principal Datacenter Electrical Engineer

Microsoft Corporation

Redmond, Washington • Today

Full-time

USD 142,800.00 - 274,800.00 per year

Sr Software Engineer - AI DevEx

Compass

Seattle, Washington • Today

Full-time

USD 149,000.00 - 166,100.00 per year

Staff Software Engineer - Secondary Driving System

General Motors

Remote or Sunnyvale, California • Today

Full-time

USD 218,800.00 - 335,300.00 per year

Antenna Engineer (Starlink Mobile)

SpaceX

Redmond, Washington • Today

Full-time

USD 125,000.00 - 150,000.00 per year

Sr. Software Infrastructure Engineer (Starlink)

SpaceX

Redmond, Washington • Today

Full-time

USD 165,000.00 - 230,000.00 per year

Software Infrastructure Engineer (Starlink)

SpaceX

Redmond, Washington • Today

Full-time

USD 125,000.00 - 150,000.00 per year

GMS Applications Engineer with Energy Management System Exp

Agile Global Solutions, Inc

Remote • 16d ago

Easy Apply

Contract

Depends on Experience

Sr. Software Engineer, DevOps (Starlink)

SpaceX

Redmond, Washington • Today

Full-time

USD 165,000.00 - 230,000.00 per year

Software Development Engineer

Zoom Video Communications

Seattle, Washington • Today

Full-time

USD 184,030.00 - 275,400.00 per year

Software Engineer, DevOps (Starlink)

SpaceX

Redmond, Washington • Today

Full-time

USD 125,000.00 - 150,000.00 per year

IT Support Analyst

GDH

Remote • 12d ago

Easy Apply

Third Party, Contract

Depends on Experience

Guidance Navigation & Control Engineer 4

Boeing Company

Everett, Washington • Today

Full-time

Job Details

Skills

Test Execution
Testing
IQ
OQ
PQ
Regulatory Compliance
Good Manufacturing Practice
GxP
Software Development Methodology
Change Management
Life Sciences
Management
GAMP
Manufacturing Execution System
MES
Enterprise Resource Planning
SAP
Oracle
Computerized System Validation
Documentation
Test Scripts
Pharmaceutics
Manufacturing
IT Service Management
ServiceNow
Quality Management
Veeva

Summary

Job Summary:

We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications.
The CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle.
The primary responsibility is to ensure that validation activities supporting Manufacturing Execution Systems (MES) are documented in accordance with applicable procedures and regulatory requirements.

Roles & Responsibilities:

uthor, review, and/or approve applicable CSV documentation.
ssist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.
ssist Business Owners and Technical Owners in developing requirements and specifications for computerized systems used in GxP operations.
Support validation activities for Manufacturing Execution Systems (MES).
Develop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs.
Ensure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices.
Support validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments.
Utilize IT service management platforms to support incident, problem, and change management activities.
Work with Business Quality Management Systems and related validation processes.

Education & Experience:

Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience.
Minimum 4+ years of direct experience in Computer System Validation (CSV).
Strong knowledge of GAMP and risk-based validation approaches.
Good understanding of electronic records and electronic signatures.
Strong knowledge of Manufacturing Execution System (MES) validation.
Familiarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch.
Strong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs.
Knowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing.
Experience with IT service management platforms such as ServiceNow.
Exposure to Business Quality Management Systems such as Veeva.

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: ba18ae94366ddadea42d67b8ab851684
Posted 30+ days ago

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Similar Jobs

CSV Engineer

Seattle, Washington

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Today

Job Description: The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). This role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client. By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensur

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CSV Engineer

New Jersey

•

Today

Job Description: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer

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Senior CQV Engineer/Validation Engineer

No location provided

•

Today

Direct hire /Full time On-site Boulder, CO Salary expectation: You povide Summary We are seeking a highly motivated Senior CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotechnology manufacturing facilities. The successful candidate will lead and execute CQV deliverables associated with GMP-regulated process equipment, utilities, automation systems, cleanrooms, and manufacturing operations. This role requires hands-on technical expertis

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$DOE

Engineer Pharma Validation

Remote

•

Today

Job Summary Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Assist in authoring and executing protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results within a controlled environment. Responsible for managing and or performing reval

Full-time

USD 73,000.00 - 110,000.00 per year

Job Details

Skills

Test Execution
Testing
IQ
OQ
PQ
Regulatory Compliance
Good Manufacturing Practice
GxP
Software Development Methodology
Change Management
Life Sciences
Management
GAMP
Manufacturing Execution System
MES
Enterprise Resource Planning
SAP
Oracle
Computerized System Validation
Documentation
Test Scripts
Pharmaceutics
Manufacturing
IT Service Management
ServiceNow
Quality Management
Veeva

Summary

Job Summary:

We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications.
The CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle.
The primary responsibility is to ensure that validation activities supporting Manufacturing Execution Systems (MES) are documented in accordance with applicable procedures and regulatory requirements.

Roles & Responsibilities:

uthor, review, and/or approve applicable CSV documentation.
ssist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.
ssist Business Owners and Technical Owners in developing requirements and specifications for computerized systems used in GxP operations.
Support validation activities for Manufacturing Execution Systems (MES).
Develop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs.
Ensure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices.
Support validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments.
Utilize IT service management platforms to support incident, problem, and change management activities.
Work with Business Quality Management Systems and related validation processes.

Education & Experience:

Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience.
Minimum 4+ years of direct experience in Computer System Validation (CSV).
Strong knowledge of GAMP and risk-based validation approaches.
Good understanding of electronic records and electronic signatures.
Strong knowledge of Manufacturing Execution System (MES) validation.
Familiarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch.
Strong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs.
Knowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing.
Experience with IT service management platforms such as ServiceNow.
Exposure to Business Quality Management Systems such as Veeva.

Dice Id: 91116760
Position Id: ba18ae94366ddadea42d67b8ab851684
Posted 30+ days ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Create job alert

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

Similar Jobs

CSV Engineer

Seattle, Washington

•

Today

Full-time

CSV Engineer

New Jersey

•

Today

Full-time

Senior CQV Engineer/Validation Engineer

No location provided

•

Today

Easy Apply

Full-time

$DOE

Engineer Pharma Validation

Remote

•

Today

Full-time

USD 73,000.00 - 110,000.00 per year