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Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Raleigh, North Carolina • 4d ago

Full-time

Senior Engineer, Validation

Indivior PLC

Raleigh, North Carolina • Today

Full-time

USD 88,000.00 - 105,000.00 per year

Sr. Computer Systems Validation Engineer

CooperCompanies

Remote or Trumbull, Connecticut • Today

Full-time

USD 96,441.00 - 126,000.00 per year

Validation Engineer

Katalyst Healthcares and Lifesciences

Raleigh, North Carolina • 4d ago

Full-time

Lead Validation Engineer

E Tech Group

Raleigh, North Carolina • Today

Full-time

AI Cluster Validation Engineer (Tester & Programmer)

Vy Systems

Hybrid in Morrisville, North Carolina • 12d ago

Easy Apply

Contract, Third Party

Depends on Experience

AI Cluster Validation Engineer (Tester & Programmer)

MphasiS Corporation USA

Morrisville, North Carolina • 20d ago

Easy Apply

Full-time

$100,000 - $120,000

Associate System Integration Engineer

Analog Devices, Inc.

Durham, North Carolina • Today

Full-time

USD 71,989.00 - 99,006.00 per year

Integration Validation Engineer- VHA DSO

HigherEchelon

Remote • Today

Full-time

Data Validation Engineer

ICF Consulting Group, Inc.

Remote or Reston, Virginia • Today

Full-time

USD 98,614.00 - 167,644.00 per year

Senior System Test Engineer - Simulation

Torc Robotics

Remote • Today

Full-time

USD 153,200.00 - 183,800.00 per year

NCDIT - Knowledge Manager

Datasoft Technologies, Inc.

Raleigh, North Carolina • 11d ago

Easy Apply

Contract, Third Party

Depends on Experience

Senior DevOps Validation Engineer

Keeper Security, Inc.

Remote • Today

Full-time

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

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

EZCap System Engineer

Ledgent Technology

Remote • Today

Easy Apply

Contract

$60 - $77 per hour

Senior ETL Test Engineer

UnitedHealth Group

Raleigh, North Carolina • Today

Full-time

USD 91,700.00 - 163,700.00 per year

Loftware Spectrum Technical Lead / Solution Engineer

NTT DATA Americas, Inc

Remote • Today

Easy Apply

Contract

Depends on Experience

Sr. Systems Engineer, Data Centers

Schneider Electric

Raleigh, North Carolina • Today

Full-time

USD 130,000.00 - 176,400.00 per year

Senior Value Engineer - Technology Consultant

Celonis

Raleigh, North Carolina • Today

Full-time

System Engineer II (Cloud)

Accuity

Remote • Today

Full-time

USD 95,000.00 - 125,000.00 per year

Sr Staff Systems Engineer

Becton Dickinson & Company

Durham, North Carolina • Today

Full-time

Senior NALCOMIS Virtual Environment Systems Administrator

Vectrus Corporate

Remote or Maryland • Today

Full-time

USD 115,000.00 - 120,000.00 per year

Data Engineer

GDH

Remote • Today

Easy Apply

Third Party, Contract

Depends on Experience

Senior Consultant

System One

Remote • 6d ago

Easy Apply

Contract

Depends on Experience

DBA I

Brooksource

North Carolina • Today

Contract

$35.00 - $40.00

Model Based Systems Engineer - Initial one month onsite in Atlanta then FULLY REMOTE

Synersys Technologies

Remote • 6d ago

Easy Apply

Contract

Automation & Controls Engineer

Indivior PLC

Raleigh, North Carolina • Today

Full-time

USD 98,000.00 - 115,500.00 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 Description:

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.

Requirements:

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: 73b534442489e366df70569ff9238f99
Posted 30+ days ago

Fitment

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Similar Jobs

Senior Engineer, Validation

Raleigh, North Carolina

•

Today

TITLE: Senior Engineer, Validation WHO WE ARE Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of p

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Sr. Software Validation Engineer

Raleigh, North Carolina

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Senior Software Validation / Test Engineer Monday to Friday (On-site required) Contribute immediately, please ensure that only candidates with directly relevant experience are submitted. Important Requirements 1. Candidates must currently reside in the Raleigh area or be willing to permanently relocate to Raleigh for the duration of the engagement. 2. This position requires onsite attendance Monday through Friday. 3. This is a hands-on individual contributor role. Candidates must be comfortable

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CSV Lead

Hybrid in Durham, North Carolina

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6d ago

Role - CSV Lead Location- Durham, NC (Hybrid, must visit site 2-3 days a week) Job Description- Must have worked in CSV in Manufacturing automation systems like DELTA V,PI Historian, PLC, LAB Automation Systems(any one pf the systems or all). Primary: CSV (Computer System Validation) Compliance Secondary: SDLC / CSA / Validation Governance / Quality Compliance. Hands-on experience supporting validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical

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Engineer II, Computer Systems Validation

Greenville, North Carolina

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our

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 Description:

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.

Requirements:

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: 73b534442489e366df70569ff9238f99
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

Senior Engineer, Validation

Raleigh, North Carolina

•

Today

Full-time

USD 88,000.00 - 105,000.00 per year

Sr. Software Validation Engineer

Raleigh, North Carolina

•

21d ago

Easy Apply

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CSV Lead

Hybrid in Durham, North Carolina

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6d ago

Easy Apply

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Engineer II, Computer Systems Validation

Greenville, North Carolina

•

Today

Full-time