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Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Phoenix, Arizona • 12d ago

Full-time

GxP Systems Lead / PM - Pharma

Ekman Associates, Inc.

Remote • 6d ago

Easy Apply

Full-time

Depends on Experience

Sr. Computer Systems Validation Engineer

CooperCompanies

Remote or Trumbull, Connecticut • Today

Full-time

Validation Engineer

SiTime

Tempe, Arizona • Today

Full-time

USD 93,500.00 - 128,590.00 per year

Validation Engineer

Texas Instruments Incorporated

Chandler, Arizona • Today

Full-time

AI & Computer Vision Engineer

Prime Solutions Group, Inc (PSG)

Goodyear, Arizona • Today

Full-time

USD 110,000.00 per year

Integration Validation Engineer- VHA DSO

HigherEchelon

Remote • Today

Full-time

Senior FPGA Engineer

TalentBridge

Chandler, Arizona • 29d ago

Easy Apply

Full-time

$120000 - $150000

Senior System Test Engineer - Simulation

Torc Robotics

Remote • Today

Full-time

USD 153,200.00 - 183,800.00 per year

Virtual Propulsion Engineer- Power Electronics & HV System

General Motors

Remote or Warren, Michigan • Today

Full-time

Senior Software Engineer: Fleet Enablement & Insights (Map Validation & Annotation Platform)

Torc Robotics

Remote or Ann Arbor, Michigan • Today

Full-time

USD 160,800.00 - 193,000.00 per year

Cybersecurity Validation and Test Engineer

Amyx Inc

Remote • Today

Full-time

USD 100,000.00 - 140,000.00 per year

Virtual Propulsion Engineer - Focus with either Structural, Durability, Dynamics, NVH, Sealing, Fastening, Cranktrain and/or Fatigue Analysis

General Motors

Remote or Warren, Michigan • Today

Full-time

MES Engineer

Katalyst Healthcares and Lifesciences

Phoenix, Arizona • 12d ago

Full-time

System Engineer II (Cloud)

Accuity

Remote • Today

Full-time

USD 95,000.00 - 125,000.00 per year

Onsite Technical Lead - Data Engineering

ITC Infotech (USA), Inc

Tempe, Arizona • 8d ago

Easy Apply

Full-time

120,000 - 140,000

Data Scientist

TalentBridge

Phoenix, Arizona • 28d ago

Easy Apply

Full-time, Third Party

$100000 - $120000

Systems Engineer, Digital Payload

Viasat, Inc.

Tempe, Arizona • Today

Full-time

USD 180,500.00 - 285,000.00 per year

Data System Engineer III

Franciscan Health

Remote • Today

Full-time

USD 82,931.74 - 114,031.14 per year

Principal System Db2 Software Engineer - Remote

UnitedHealth Group

Remote or Eden Prairie, Minnesota • Today

Full-time

USD 112,700.00 - 193,200.00 per year

Space Systems Engineer- MBSE

General Dynamics

Scottsdale, Arizona • Today

Full-time

USD 95,384.00 - 105,817.00 per year

Engineer, Engineering

Judge Group, Inc.

Tempe, Arizona • Today

Contract

USD 45.00 - 54.00 per hour

EZCap System Engineer

Ledgent Technology

Remote • Today

Easy Apply

Contract

$60 - $77 per hour

Databricks Engineer- Remote

Centillion Infotech

Remote • Today

Easy Apply

Contract, Third Party

$50 - $55

MES Deployment Engineer

Techgroup America Inc.

Remote • 12d ago

Easy Apply

Contract

Depends on Experience

Controls Engineer, Distributed Control System (DCS)

NAES

Remote or McKittrick, California • Today

Full-time

USD 140,000.00 - 165,000.00 per year

DevSecOps Engineer

9th Way Insignia

Remote • 26d ago

Full-time

$98135.18 - $135000

Senior NALCOMIS Virtual Environment Systems Administrator

Vectrus Corporate

Remote or Maryland • Today

Full-time

USD 115,000.00 - 120,000.00 per year

Systems Engineer I - Software, Robotics & Semiconductor Automation

ASM America, Inc.

Phoenix, Arizona • Today

Full-time

DevOps Engineer (W2 only)

System One

Remote • 2d ago

Easy Apply

Contract

Depends on Experience

Job Details

Skills

Computerized System Validation
Lifecycle Management
Operational Efficiency
Good Manufacturing Practice
Computer Hardware
Training
Testing
Risk Assessment
Change Management
Backup
Configuration Management
Documentation
Acceptance Testing
Traceability Matrix
Collaboration
Communication
Quality Assurance
Quality Control
Pharmaceutical Industry
Regulatory Compliance
Data Integrity
Cross-functional Team
Data Governance
HPLC
TOC
Theory Of Constraints
Microsoft Excel
Computer Science
Science

Computerized System Validation
Lifecycle Management
Operational Efficiency
Good Manufacturing Practice
Computer Hardware
Training
Testing
Risk Assessment
Change Management
Backup
Configuration Management
Documentation
Acceptance Testing
Traceability Matrix
Collaboration
Communication
Quality Assurance
Quality Control
Pharmaceutical Industry
Regulatory Compliance
Data Integrity
Cross-functional Team
Data Governance
HPLC
TOC
Theory Of Constraints
Microsoft Excel
Computer Science
Science

Summary

Job Description:

In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.

Responsibilities:

pply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.
Facilitate risk assessments to identify validation deliverables and project requirements.
Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.
Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.
nalyze validation data and troubleshoot issues in collaboration with technical teams.
Maintain communication with stakeholders to address system needs, validation progress, and related concerns.

Requirements:

Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.
Hands-on experience in validating computerized systems.
Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.
bility to work effectively in a dynamic, cross-functional team environment.
Proven expertise in applying data governance measures and creating impactful data visualizations.
Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.
Bachelor's degree in computer science, Engineering, Biological Sciences, or a related field.

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: 6e61bfce3aa62f2dba5aa4dbcacb5e9c
Posted 30+ days ago

Fitment

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Similar Jobs

CSV and Validation Engineer

New Jersey

•

12d ago

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument s

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CSV Lead Consultant at Princeton, NJ (Hybrid, 3 days in Office) || W2 Only

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CSV Lead Consultant Princeton, NJ (Hybrid, 3 days in Office) Long Term Contract Mandatory Skills- Computer System Validation (CSV), GxP Systems & Compliance, Manufacturing Domain Knowledge, Labeling Systems Knowledge, Validation Testing (IQ/OQ/PQ) , Validation Documentation , FDA 21 CFR Part 11 / GAMP5 , Risk Assessment & Change Control , Stakeholder Management , Audit & Inspection Support Role Summary We are seeking an experienced Computer System Validation (CSV) Professional with strong exper

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Computerized System Validation (CSV) Consultant @ Remote

Remote

•

Yesterday

Position: Computerized System Validation (CSV) Consultant Location: Remote Duration: long Term Contract Job Description: We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation/Computerized System Assurance, Risk Management, Test Management and Audits.Below are the role expectations:5 10 years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry.Good underst

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Senior Engineer, Process Validation

Remote

•

Today

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Aldevron, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the spee

Full-time

USD 100,000.00 - 130,000.00 per year

Job Details

Skills

Computerized System Validation
Lifecycle Management
Operational Efficiency
Good Manufacturing Practice
Computer Hardware
Training
Testing
Risk Assessment
Change Management
Backup
Configuration Management
Documentation
Acceptance Testing
Traceability Matrix
Collaboration
Communication
Quality Assurance
Quality Control
Pharmaceutical Industry
Regulatory Compliance
Data Integrity
Cross-functional Team
Data Governance
HPLC
TOC
Theory Of Constraints
Microsoft Excel
Computer Science
Science

Computerized System Validation
Lifecycle Management
Operational Efficiency
Good Manufacturing Practice
Computer Hardware
Training
Testing
Risk Assessment
Change Management
Backup
Configuration Management
Documentation
Acceptance Testing
Traceability Matrix
Collaboration
Communication
Quality Assurance
Quality Control
Pharmaceutical Industry
Regulatory Compliance
Data Integrity
Cross-functional Team
Data Governance
HPLC
TOC
Theory Of Constraints
Microsoft Excel
Computer Science
Science

Summary

Job Description:

In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency.

Responsibilities:

pply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.
Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies.
Facilitate risk assessments to identify validation deliverables and project requirements.
Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews.
Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.
nalyze validation data and troubleshoot issues in collaboration with technical teams.
Maintain communication with stakeholders to address system needs, validation progress, and related concerns.

Requirements:

Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.
Hands-on experience in validating computerized systems.
Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.
bility to work effectively in a dynamic, cross-functional team environment.
Proven expertise in applying data governance measures and creating impactful data visualizations.
Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation.
Bachelor's degree in computer science, Engineering, Biological Sciences, or a related field.

Dice Id: 91116760
Position Id: 6e61bfce3aa62f2dba5aa4dbcacb5e9c
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

CSV and Validation Engineer

New Jersey

•

12d ago

Full-time

CSV Lead Consultant at Princeton, NJ (Hybrid, 3 days in Office) || W2 Only

Hybrid in New Jersey

•

Today

Easy Apply

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Computerized System Validation (CSV) Consultant @ Remote

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Yesterday

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Depends on Experience

Senior Engineer, Process Validation

Remote

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Today

Full-time

USD 100,000.00 - 130,000.00 per year