Search Jobs | Dice.com

68 results (5 new)

Group by company

Computer System Validation - GxP/R&D

ASCII Group LLC

Wilmington, Delaware • Today

Easy Apply

Full-time

Depends on Experience

Senior Computer System Validation (CSV) Engineer

Galaxy i Technologies, Inc.

Wilmington, Delaware • Today

Contract, Third Party

Depends on Experience

Senior Computer System Validation (CSV) Engineer

Galaxy i Technologies, Inc.

Wilmington, Delaware • Today

Third Party, Contract

Depends on Experience

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Wilmington, Delaware • 19d ago

Full-time

Loftware Spectrum Technical Lead / Solution Engineer

NTT DATA Americas, Inc

Remote • 15d ago

Easy Apply

Contract

Depends on Experience

SAP Validation

Devfi

Remote • 28d ago

Easy Apply

Contract

Depends on Experience

Associate Automation Engineer - 2nd Shift

GSK

King of Prussia, Pennsylvania • Today

Full-time

Veeva eTMF/CTMS Configuration

Arnex Solutions LLC

Remote • Today

Full-time, Third Party

Depends on Experience

Technical Project Manager - SaMD / GxP Validation

Medasource

Remote • Today

Contract

$60.00 - $80.00

Computer Systems Validation Engineer

Praxis Precision Medicines

Remote • Today

Full-time

USD 150,000.00 - 178,000.00 per year

Hardware Validation Lead

KRG Technologies Inc

Philadelphia, Pennsylvania • 29d ago

Easy Apply

Contract

35 - 40

Business Systems Analyst III

Milestone Technologies, Inc.

Remote • 11d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Milestone Technologies, Inc.

Remote • 11d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Milestone Technologies, Inc.

Remote • 11d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Milestone Technologies, Inc.

Remote • 11d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Milestone Technologies, Inc.

Remote • 11d ago

Easy Apply

Contract

Depends on Experience

Loftware Spectrum Technical Lead

ARK Infotech Spectrum

Remote • 4d ago

Easy Apply

Third Party, Contract

Depends on Experience

Sr. Computer Systems Validation Engineer

CooperCompanies

Remote or Trumbull, Connecticut • Today

Full-time

USD 96,441.00 - 126,000.00 per year

Managed Services / Business Apps Operations Lead (DWH)

SolutionIT, Inc.

Remote • Today

Easy Apply

Contract, Third Party

Cloud & Hosting - Senior Product Owner - Modern Engineering

GSK

Philadelphia, Pennsylvania • Today

Full-time

Platform Information Security Officer (PISO), Life Sciences Platform

Danaher Corporation

Remote • Today

Full-time

USD 225,000.00 - 275,000.00 per year

Loftware Spectrum Technical Lead / Solution Engineer

NTT DATA, Inc.

Remote or Plano, Texas • Today

Full-time

Sr. Principal Software and AI Engineer

BeiGene, Inc.

Remote • Today

Full-time

USD 137,400.00 - 182,400.00 per year

Director, DSPV Data, Technology and Innovation

Insmed Incorporated

Remote or New Jersey • Today

Full-time

USD 185,000.00 - 252,500.00 per year

Senior Manager, Global Digital & Technology Systems, Veeva Administrator

BeiGene, Inc.

Remote • Today

Full-time

USD 136,900.00 - 181,900.00 per year

Director, I&T Plasma Engineering

CSL Plasma

King of Prussia, Pennsylvania • Today

Full-time

Senior Manager, AI Innovation and Strategy - Life Sciences - Remote

UnitedHealth Group

Remote or Eden Prairie, Minnesota • Today

Full-time

USD 112,700.00 - 193,200.00 per year

GxP Systems and Support Administrator

CAI

Remote • Today

Full-time

USD 130,000.00 - 150,000.00 per year

Director, AI Innovation and Strategy - Life Sciences - Remote

UnitedHealth Group

Remote or Eden Prairie, Minnesota • Today

Full-time

USD 134,600.00 - 230,800.00 per year

Head of Forward Deployed Engineering

Bausch & Lomb

Remote or Oregon • Today

Full-time

USD 190,000.00 - 240,000.00 per year

Job Details

Skills

Life Sciences
Computerized System Validation
Corrective And Preventive Action
ITIL
Auditing
Identity Management
Management
Pharmaceutics
Regulatory Affairs
Biostatistics
Documentation
Research and Development
GxP
ISO 9000
Inspection
Regulatory Compliance
GAMP
Risk Assessment
Risk-based Testing
Robotic Process Automation
Sarbanes-Oxley
Artificial Intelligence
URS
Veeva
Testing

Summary

Hi ,

The following requirement is open with our client.

Title : Computer System Validation - GxP/R&D

Location : Wilmington, DE (Onsite)

Duration : 6+ Months

Relevant Experience (in Yrs.): 8+
Looking for only W2/C2C

Job Description

We are seeking an experienced Senior Computer System Validation (CSV) Specialist with 8+ years of overall experience, including at least 5 years of hands-on experience validating GxP-regulated computer systems. The ideal candidate will have strong expertise in regulatory compliance, risk-based validation, validation lifecycle documentation, audit readiness, and quality processes, along with an understanding of pharmaceutical and life sciences R&D systems.

Key Responsibilities

Execute and support end-to-end CSV activities for GxP-regulated systems in compliance with applicable regulatory requirements.
Prepare, review, and maintain validation documentation, including URS, Functional Specifications (FS), validation plans, test protocols, execution evidence, and final validation reports.
Apply risk-based testing and Computer Software Assurance (CSA) principles to validation activities.
Support audit and inspection readiness, periodic reviews, access roster reviews, and audit trail reviews.
Manage deviations, CAPAs, validation issues, and compliance documentation in accordance with established SOPs and quality policies.
Support validation and compliance activities for R&D applications, including clinical, regulatory, pharmacovigilance, and medical affairs systems.
Contribute to compliance assessments for Veeva Vault applications, RPA-based GxP bots, and AI-enabled solutions in regulated R&D environments.

Required Skills

Strong knowledge of GxP regulations, 21 CFR Part 11/820, GAMP 5, EU Annex 11, SOX, ISO 9001, and ITIL.
Hands-on experience in Computer System Validation for GxP-regulated systems.
Expertise in validation lifecycle documentation, including URS, FS, validation plans, test protocols, and final reports.
Experience with risk assessments, risk-based testing, and CSA fundamentals.
Knowledge of audit readiness, periodic reviews, access management, audit trail reviews, deviations, and CAPA management.
Understanding of pharmaceutical and life sciences R&D processes, including Clinical, Biostatistics, Discovery, Medical Affairs, Pharmacovigilance, and Regulatory Affairs.
High-level understanding of Veeva Vault applications and emerging GxP technologies, including RPA bots and AI-enabled solutions.

MUST-HAVE SKILLS

GxP Computer System Validation (CSV)
21 CFR Part 11 / GAMP 5
CSV Documentation
Risk-Based Testing / CSA

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: 10117479
Position Id: 9126797
Posted 6 hours 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.

Contact the job poster

Arun Potula

IT Recruiter @ ASCII Group LLC

View Profile

Create job alert

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

Wilmington, Delaware

•

Today

Job Title : Senior Computer System Validation (CSV) Engineer Location :Wilmington, DE JD : Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelors in Pharmacy Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system Knowledge, Experience and Skills: { CORE CSV 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic revie

Third Party, Contract

Depends on Experience

Senior Computer System Validation (CSV) Engineer

Wilmington, Delaware

•

Today

Job Title : Senior Computer System Validation (CSV) Engineer Location :Wilmington, DE Long term Contract JD : PLEASE NOTE The rates may be negotiable based on experience, education, geographic location, and other factors.. Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelors in Pharmacy Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system Knowledge, Experience and Skills: { CORE CSV 21 CFR P

Contract, Third Party

Depends on Experience

Computer System Validation Engineer

Wilmington, Delaware

•

19d ago

Roles & Responsibilities : 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes uthoring of URS/FS, protocols, final reports, validation plan/report High-level understanding of Veeva Vault suits Risk-based testing aligned to CSA fundamentals High-level understanding of Biostatistics, Clinical, Discovery, Med

Full-time

Computer Systems Validation Engineer

Remote

•

Today

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role: you'll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.

Full-time

USD 150,000.00 - 178,000.00 per year

Job Details

Skills

Life Sciences
Computerized System Validation
Corrective And Preventive Action
ITIL
Auditing
Identity Management
Management
Pharmaceutics
Regulatory Affairs
Biostatistics
Documentation
Research and Development
GxP
ISO 9000
Inspection
Regulatory Compliance
GAMP
Risk Assessment
Risk-based Testing
Robotic Process Automation
Sarbanes-Oxley
Artificial Intelligence
URS
Veeva
Testing

Summary

Hi ,

The following requirement is open with our client.

Title : Computer System Validation - GxP/R&D

Location : Wilmington, DE (Onsite)

Duration : 6+ Months

Relevant Experience (in Yrs.): 8+
Looking for only W2/C2C

Job Description

Key Responsibilities

Execute and support end-to-end CSV activities for GxP-regulated systems in compliance with applicable regulatory requirements.
Prepare, review, and maintain validation documentation, including URS, Functional Specifications (FS), validation plans, test protocols, execution evidence, and final validation reports.
Apply risk-based testing and Computer Software Assurance (CSA) principles to validation activities.
Support audit and inspection readiness, periodic reviews, access roster reviews, and audit trail reviews.
Manage deviations, CAPAs, validation issues, and compliance documentation in accordance with established SOPs and quality policies.
Support validation and compliance activities for R&D applications, including clinical, regulatory, pharmacovigilance, and medical affairs systems.
Contribute to compliance assessments for Veeva Vault applications, RPA-based GxP bots, and AI-enabled solutions in regulated R&D environments.

Required Skills

Strong knowledge of GxP regulations, 21 CFR Part 11/820, GAMP 5, EU Annex 11, SOX, ISO 9001, and ITIL.
Hands-on experience in Computer System Validation for GxP-regulated systems.
Expertise in validation lifecycle documentation, including URS, FS, validation plans, test protocols, and final reports.
Experience with risk assessments, risk-based testing, and CSA fundamentals.
Knowledge of audit readiness, periodic reviews, access management, audit trail reviews, deviations, and CAPA management.
Understanding of pharmaceutical and life sciences R&D processes, including Clinical, Biostatistics, Discovery, Medical Affairs, Pharmacovigilance, and Regulatory Affairs.
High-level understanding of Veeva Vault applications and emerging GxP technologies, including RPA bots and AI-enabled solutions.

MUST-HAVE SKILLS

GxP Computer System Validation (CSV)
21 CFR Part 11 / GAMP 5
CSV Documentation
Risk-Based Testing / CSA

Dice Id: 10117479
Position Id: 9126797
Posted 6 hours 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.

Contact the job poster

Arun Potula

IT Recruiter @ ASCII Group LLC

View Profile

Create job alert

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

Wilmington, Delaware

•

Today

Third Party, Contract

Depends on Experience

Senior Computer System Validation (CSV) Engineer

Wilmington, Delaware

•

Today

Contract, Third Party

Depends on Experience

Computer System Validation Engineer

Wilmington, Delaware

•

19d ago

Full-time

Computer Systems Validation Engineer

Remote

•

Today

Full-time

USD 150,000.00 - 178,000.00 per year

Computer System Validation - GxP/R&D

Skills

Summary

Dice Job Match Score™

Arun Potula

Similar Jobs

Computer System Validation - GxP/R&D

Job Details

Skills

Summary

Dice Job Match Score™

Arun Potula

Similar Jobs