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CSV and Validation Engineer

Katalyst Healthcares and Lifesciences

New Jersey • Today

Full-time

Computer System Validation (CSV) Engineer

Spadtek Solutions LLC

Piscataway, New Jersey • 2d ago

Easy Apply

Full-time, Third Party

Depends on Experience

Sr. CSV/CSA/Validation Engineer

Katalyst Healthcares and Lifesciences

Raritan, New Jersey • Today

Full-time

CSV Engineer

Katalyst Healthcares and Lifesciences

Raritan, New Jersey • Today

Full-time

CSV Engineer

Katalyst Healthcares and Lifesciences

New Jersey • Today

Full-time

Test Engineer

Saicon Consultants Inc.

Bloomfield, New Jersey • 4d ago

Easy Apply

Third Party, Contract

Depends on Experience

Computer Systems Validation Engineer

Praxis Precision Medicines

Remote • Today

Full-time

USD 150,000.00 - 178,000.00 per year

Data Warehouse/Microsoft Fabric Engineer

Parsons Services Company

Remote • Today

Full-time

USD 88,400.00 - 154,700.00 per year

Staff Software Engineer, Backend (Platform)

Hex Technologies

Remote or New York, New York • Today

Full-time

USD 221,250.00 - 348,500.00 per year

Senior Data Engineer

Machinify

Remote • Today

Full-time

USD 180,000.00 - 220,000.00 per year

CQV Engineer, General Application

IPS-Integrated Project Services

New Jersey • Today

Full-time

USD 5,000.00 per month

Data Engineer III

SelectQuote Insurance Services

Remote • Today

Full-time

USD 115,000.00 per year

Software Engineer II

Tempus

Remote or California • Today

Full-time

USD 85,000.00 - 130,000.00 per year

Staff Software Engineer, Full-stack

Onebrief, Inc

Remote • Today

Full-time

USD 205,000.00 - 230,000.00 per year

Software Testing Engineer

Conduent

Remote or Georgia • Today

Full-time

USD 60,000.00 - 87,000.00 per year

Sr. IAM Engineer, Infrastructure Services

Insmed Incorporated

Remote or New Jersey • Today

Full-time

USD 133,000.00 - 173,000.00 per year

Staff Software Engineer, Data and Partner Platform

EnergyHub, Inc.

Remote • Today

Full-time

USD 160,000.00 - 180,000.00 per year

Senior Infrastructure Engineer

Pi-Square Technologies

Jersey City, New Jersey • Today

Full-time

USD 50.00 - 60.00 per hour

Senior Manager, Platform Engineering

Thermo Fisher Scientific

Remote or North Carolina • Today

Full-time

USD 130,000.00 - 170,000.00 per year

Senior Engineer I, Site Automation (Hopewell, NJ)

BeiGene, Inc.

Hopewell, New Jersey • Today

Full-time

USD 114,700.00 - 154,700.00 per year

CSV Engineer

Katalyst Healthcares and Lifesciences

New Jersey • Today

Full-time

Job Details

Skills

Informatics
Documentation
Test Plans
Data-flow Diagrams
Backup
Recovery
Auditing
Traceability Matrix
Management
Corrective And Preventive Action
Change Control
Training
Collaboration
Quality Assurance
Computerized System Validation
Life Sciences
Data Integrity
GAMP
URS
FRS
DS
DirectShow
RTM
IQ
OQ
PQ
LIMS
ELN
Middleware
Application Lifecycle Management
JIRA
Veeva
Master Control
Trackwise
Technical Writing
Communication

Summary

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 software and lab systems; author URS, FRS, DS, test plans, IQ/OQ/PQ, traceability, and validation summary reports.
Design and maintain infrastructure and data flow diagrams covering integrations, security, backup/restore, and audit trails.
Capture business and technical requirements; maintain a bidirectional requirements traceability matrix.
Execute test cycles, log defects, drive remediation, manage deviations/CAPA, and support inspections.
Ensure change control, periodic review, training effectiveness, and release readiness for validated systems.
Collaborate across QA/CSV, IT, and Lab teams; provide clear communication and stakeholder updates.
Requirements:
5 to 10+ years in CSV/validation within regulated labs or life sciences.
Strong knowledge of EMA Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and GAMP 5.
Proven authorship of URS/FRS/DS, RTM, IQ/OQ/PQ, and validation summary reports.
Experience with LIMS, ELN, CDS, or instrument control software; familiarity with instrument integrations and middleware.
Proficiency with test and quality tools such as Client ALM/Jira/Xray, ValGenesis, Veeva, MasterControl, or TrackWise.
Excellent technical writing, organization, and cross- functional communication.

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: 4b8bfdf3b7a8599ade8b4b6f7fcd97ea
Posted 1 day ago

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Job Details

Skills

Informatics
Documentation
Test Plans
Data-flow Diagrams
Backup
Recovery
Auditing
Traceability Matrix
Management
Corrective And Preventive Action
Change Control
Training
Collaboration
Quality Assurance
Computerized System Validation
Life Sciences
Data Integrity
GAMP
URS
FRS
DS
DirectShow
RTM
IQ
OQ
PQ
LIMS
ELN
Middleware
Application Lifecycle Management
JIRA
Veeva
Master Control
Trackwise
Technical Writing
Communication

Summary

Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5.
Validate instrument software and lab systems; author URS, FRS, DS, test plans, IQ/OQ/PQ, traceability, and validation summary reports.
Design and maintain infrastructure and data flow diagrams covering integrations, security, backup/restore, and audit trails.
Capture business and technical requirements; maintain a bidirectional requirements traceability matrix.
Execute test cycles, log defects, drive remediation, manage deviations/CAPA, and support inspections.
Ensure change control, periodic review, training effectiveness, and release readiness for validated systems.
Collaborate across QA/CSV, IT, and Lab teams; provide clear communication and stakeholder updates.
Requirements:
5 to 10+ years in CSV/validation within regulated labs or life sciences.
Strong knowledge of EMA Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and GAMP 5.
Proven authorship of URS/FRS/DS, RTM, IQ/OQ/PQ, and validation summary reports.
Experience with LIMS, ELN, CDS, or instrument control software; familiarity with instrument integrations and middleware.
Proficiency with test and quality tools such as Client ALM/Jira/Xray, ValGenesis, Veeva, MasterControl, or TrackWise.
Excellent technical writing, organization, and cross- functional communication.

Dice Id: 91116760
Position Id: 4b8bfdf3b7a8599ade8b4b6f7fcd97ea
Posted 1 day ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Create job alert

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