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Validation Engineer

Katalyst Healthcares and Lifesciences

Portsmouth, New Hampshire • Today

Full-time

Computer Systems Validation Engineer

Moda Technology Partners

Portsmouth, New Hampshire • Today

Full-time

Validation Engineer

Dell Technologies

Remote or Oregon • Today

Full-time

USD 134,400.00 - 184,800.00 per year

Integration Validation Engineer- VHA DSO

HigherEchelon

Remote • Today

Full-time

Computer Systems Validation Engineer

Praxis Precision Medicines

Remote • Today

Full-time

USD 150,000.00 - 178,000.00 per year

Cybersecurity Validation and Test Engineer

Amyx Inc

Remote • Today

Full-time

USD 100,000.00 - 140,000.00 per year

Senior Software Systems Engineer, Autonomous Systems Validation Confidence

General Motors

Remote or Sunnyvale, California • Today

Full-time

USD 153,200.00 - 234,100.00 per year

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

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

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

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

QA Validation Specialist 100% Remote

Apetan Consulting

Remote • Today

Easy Apply

Contract

$40 - $444

Sr. Business Systems Analyst - Validation (CSA) Governance & Process Support

Arthrex

Remote • Today

Full-time

To define

Data Quality Engineer/Data Scientist- VHA DSO

HigherEchelon

Remote • Today

Full-time

Senior Automation Engineer- VHA DSO

HigherEchelon

Remote • Today

Full-time

Senior Synthetic Data Engineer- VHA DSO

HigherEchelon

Remote • Today

Full-time

Digital Engineering Lead (Remote)

Accenture LLP

Remote or San Antonio, Texas • Today

Full-time

USD 135,200.00 - 278,500.00 per year

Brake CAE Virtual Integration Engineer/Senior Engineer

General Motors

Remote or Warren, Michigan • Today

Full-time

Principal Site Reliability Engineer - Remote

UnitedHealth Group

Remote or Eden Prairie, Minnesota • Today

Full-time

USD 134,600.00 - 230,800.00 per year

IRS CAS (Sr Software Developer/Infrastructure Currency Engineer)

Constellation West

Remote • Today

Full-time

Senior Manager, SaaS Engineering (Tools & AI)

Ping Identity

Remote • Today

Full-time

USD 157,000.00 - 185,000.00 per year

FIS IBS / Digital One Solution Architect

Openmind Technologies

Remote • 5d ago

Easy Apply

Contract

65 - 70

FIS IBS SME / Solution Architect || Remote role

Verito Solutions

Remote • 14d ago

Easy Apply

Contract, Third Party

Depends on Experience

CSV Validation Lead

Nityo Infotech Corporation

Remote • 12d ago

Easy Apply

Contract

Depends on Experience

Computer System Validation (CSV) Manager

ClifyX

Remote • Today

Easy Apply

Contract

Depends on Experience

Offshore IT Recruiter

Sovereign Technologies

Remote • Yesterday

Easy Apply

Contract

Depends on Experience

Job Details

Skills

Team Leadership
Training
Regulatory Compliance
Test Scripts
GMP
Documentation
Quality Assurance
QMS
Change Control
Project Management
Manufacturing Engineering
Mentorship
Auditing
Computer Science
Software Engineering
GAMP
Computerized System Validation
Communication
Management

Summary

Job Description:
The CSV Specialist Level 4 provides team leadership and training to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist Level 4 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. Specialist will be involved as the QA CSV representative during small and large-scale projects.
Responsibilities:

Perform all aspects of QMS process' - Change Control, Deviations, CAPAs.
Execute all responsibilities as CSV project lead for complex projects.
Oversee all CSV lifecycle activities.
Schedule qualification activities and personnel to meet business, manufacturing, engineering and quality objectives.
Mentor junior specialists.
Revise and maintain CSV SOPs.
Assess departments standing in the business and regulatory aspects.
Function as CSV SME in Inspections and Audits.
Perform other duties as assigned.

Requirements:

Bachelor's Degree (Computer Science / Software Engineering).
Advanced - 5-10 years.
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation.
Strong written and oral communication skills.
Strong organizational and time management skills.

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: 11d4f660811ab016051cbe5005904861
Posted 30+ days ago

Fitment

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Similar Jobs

Computer Systems Validation Engineer

Portsmouth, New Hampshire

•

Today

Computer Systems Validation Engineer Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. The Computer Systems Validation (CSV) Engineer will, as an individual contributor, identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations. During the scoping portion of these improvement projects the person in this role will work with other experienced members of th

Full-time

Laboratory Systems Administrator 2

Portsmouth, New Hampshire

•

Today

Summary: Responsible for the accurate setup and loading of master data into the gLIMS according to global guidelines and data principles. This role plays a crucial part in ensuring data integrity and establishing local support structures for ongoing data management. Key Accountabilities: Perform local master data setup and load in alignment with global guidelines and data principles. Build and input all initially required master data into the global LIMS system, including consumables, sampling p

Full-time

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Waltham, Massachusetts

•

Today

Job Description This position provides leadership and accountability for Digital Quality across the organization's Quality, Regulatory, and R&D systems landscape, with responsibility for supporting computer system validation activities in alignment with applicable regulatory expectations, internal procedures, and data integrity requirements. The role is focused on ensuring GxP computerized systems are implemented, maintained, and governed in a compliant, risk-based, and inspection-ready manner

Full-time

USD 110,000.00 - 126,000.00 per year

Computer Systems Validation Engineer

Boston, Massachusetts

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our Foundational Principles: - W

Full-time

USD 75,000.00 - 106,000.00 per year

Job Details

Skills

Team Leadership
Training
Regulatory Compliance
Test Scripts
GMP
Documentation
Quality Assurance
QMS
Change Control
Project Management
Manufacturing Engineering
Mentorship
Auditing
Computer Science
Software Engineering
GAMP
Computerized System Validation
Communication
Management

Summary

Perform all aspects of QMS process' - Change Control, Deviations, CAPAs.
Execute all responsibilities as CSV project lead for complex projects.
Oversee all CSV lifecycle activities.
Schedule qualification activities and personnel to meet business, manufacturing, engineering and quality objectives.
Mentor junior specialists.
Revise and maintain CSV SOPs.
Assess departments standing in the business and regulatory aspects.
Function as CSV SME in Inspections and Audits.
Perform other duties as assigned.

Requirements:

Bachelor's Degree (Computer Science / Software Engineering).
Advanced - 5-10 years.
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation.
Strong written and oral communication skills.
Strong organizational and time management skills.

Dice Id: 91116760
Position Id: 11d4f660811ab016051cbe5005904861
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

Computer Systems Validation Engineer

Portsmouth, New Hampshire

•

Today

Full-time

Laboratory Systems Administrator 2

Portsmouth, New Hampshire

•

Today

Full-time

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Waltham, Massachusetts

•

Today

Full-time

USD 110,000.00 - 126,000.00 per year

Computer Systems Validation Engineer

Boston, Massachusetts

•

Today

Full-time

USD 75,000.00 - 106,000.00 per year