Search Jobs | Dice.com

15 results (0 new)

Group by company

CSV Engineer

Katalyst Healthcares and Lifesciences

Cambridge, Massachusetts • 3d ago

Full-time

CSV Engineer (Analyst II)

Katalyst Healthcares and Lifesciences

Cambridge, Massachusetts • 3d ago

Full-time

CSV Validation Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts • 3d ago

Full-time

CSV Systems Engineer III

Curia, Inc.

Hopkinton, Massachusetts • Today

Full-time

USD 122,800.00 - 145,300.00 per year

CSV (Computer System Validation) Lead

NexInfo Solutions, Inc.

Remote • Yesterday

Easy Apply

Contract, Third Party

80 - 85

Senior Apache NiFi Data Engineer

Cyma Systems Inc

Remote • 3d ago

Easy Apply

Contract, Third Party

Depends on Experience

Lead Data Engineer

Flagship Pioneering, Inc.

Cambridge, Massachusetts • Today

Full-time

USD 128,000.00 - 176,000.00 per year

Data Migration Engineer

RadNet

Somerville, Massachusetts • Today

Full-time

USD 90,000.00 per year

Computer Systems Validation Engineer

CAI

Boston, Massachusetts • Today

Full-time

USD 75,000.00 - 106,000.00 per year

Computer Systems Validation Engineer

Praxis Precision Medicines

Remote • Today

Full-time

USD 150,000.00 - 178,000.00 per year

Lead Clinical Data Engineer

Yale University

Remote or Connecticut • Today

Full-time

USD 90,000.00 - 165,750.00 per year

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

Alkermes, Inc

Waltham, Massachusetts • Today

Full-time

USD 110,000.00 - 126,000.00 per year

Cybersecurity Data Engineer(Cribl and Vector)-W2 only

Yochana IT Solutions

Remote or Kansas • Today

Easy Apply

Contract

Senior Data Engineer

Machinify

Remote • Today

Full-time

USD 180,000.00 - 220,000.00 per year

Data Engineer

INflow Federal

Remote or Arlington, Virginia • Today

Full-time

USD 70,000.00 - 90,000.00 per year

Job Details

Skills

Cloud Computing
Technical Drafting
System Documentation
Lifecycle Management
GAMP
URS
Software Requirements Specification
FRS
RTM
Acceptance Testing
IQ
OQ
PQ
Risk Assessment
Reporting
Documentation
Testing
Corrective And Preventive Action
IT Service Management
Computer Science
Manufacturing
Good Manufacturing Practice
Data Integrity
SaaS
PaaS
IaaS
Computerized System Validation
GxP
Regulatory Compliance
Management
Quality Management
Change Control
Network
Communication
Microsoft Office
Microsoft Excel
Motivation
Mentorship
LIMS
Master Control
SAP
Element Management System
EMS
IT Infrastructure

Cloud Computing
Technical Drafting
System Documentation
Lifecycle Management
GAMP
URS
Software Requirements Specification
FRS
RTM
Acceptance Testing
IQ
OQ
PQ
Risk Assessment
Reporting
Documentation
Testing
Corrective And Preventive Action
IT Service Management
Computer Science
Manufacturing
Good Manufacturing Practice
Data Integrity
SaaS
PaaS
IaaS
Computerized System Validation
GxP
Regulatory Compliance
Management
Quality Management
Change Control
Network
Communication
Microsoft Office
Microsoft Excel
Motivation
Mentorship
LIMS
Master Control
SAP
Element Management System
EMS
IT Infrastructure

Summary

Summary :
The Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems, including both on premises and Cloud/Server based applications, are validated and controlled in compliance with industry standards and regulations. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, conducting risk assessment, and providing validation lifecycle management.

Roles & Responsibilities :

Provide CSV and CSA-based compliance guidance to the IT function, system owners, and business stakeholders, applying a risk-based approach focused on patient safety, product quality, and data integrity.
Lead the development, harmonization, implementation, and adherence to CSV and CSA procedures, ensuring validation effort is commensurate with system risk, intended use, and GxP impact.
Generate/Revise/Execute system life cycle deliverables using a risk-based CSA methodology and GAMP 5 guidelines (including URS, SRS, FRS, DDS, RTM, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Risk Assessments and Final Validation Summary Report as applicable)
Evaluate proposed new computerized systems and software to determine GxP impact, system criticality, and intended use, and define a CSA aligned validation strategy that balances compliance, efficiency, and business needs.
Review and assess vendor supplied documentation and testing evidence, leveraging supplier activities where appropriate, and perform independent risk-based verification to ensure compliance with internal requirements and regulatory expectations.
Support change control activities, deviation resolution, CAPA, and effectiveness checks for computer systems.
Manage and execute decommissioning activities for retired or end of life systems.
Ensure that suppliers of IT services and solutions are properly assessed to determine their level of compliance and ensure that appropriate controls are in place based on risk

Education & Experience :

Bachelor's degree in Engineering, Computer Science or related discipline.
Must have 3-5+ years of CSV experience in an FDA regulated industry.
Strong knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA 21 CFR Part 11and EU Annex 11 regulations and standards.
Understanding of data integrity requirements and how to perform assessments.
Knowledge and experience with qualifying on premises and externally hosted (SaaS, PaaS, IaaS) software systems.
Ability to work with and influence people at all levels in matters related to CSV,CSA and GxP compliance.
Demonstrated experience in successfully managing complex validation projects and maintaining validation requirements and timelines.
Understanding of quality systems such as change control and discrepancy investigations.
Experience working with IT for qualification of network and infrastructure.
Demonstrated written and verbal communication skills.
Proficient with Microsoft Office, particularly Word and Excel.
High degree of initiative and self-motivation.
Experience creating technical, written content.
Ability to mentor team members and colleagues.
Experience with systems like LabWare LIMS, MasterControl, SAP, Blue Mountain, Environmental Monitoring Systems (EMS), and IT infrastructure components.

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: 2560b2de28b5f850f07a91139c07d03a
Posted 3 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 Engineer (Analyst II)

Cambridge, Massachusetts

•

3d ago

About the job: The Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems, including both on premises and Cloud/Server based applications, are validated and controlled in compliance with industry standards and regulations. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, conducting risk assessment, and providing valida

Full-time

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

CSV Validation Engineer

Boston, Massachusetts

•

3d ago

Job Summary We are seeking a Medical Device Quality / CSV Validation Engineer to support quality system compliance, CAPA remediation, spreadsheet validation, and computer system/software validation activities within a regulated medical device environment. The ideal candidate will have strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk Roles & Responsibilities Review spreadsheet inventories and assess validation requirements based on applicable procedures, risk, and quality standards. Perfo

Full-time

CSV Systems Engineer III

Hopkinton, Massachusetts

•

Today

Job Description CSV Systems Engineer in Hopkinton, MA Build your future at Curia, where our work has the power to save lives. The CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the necessary tools to provide quality metrics, measurements, and reports for internal audits and inspections. Curia is a g

Full-time

USD 122,800.00 - 145,300.00 per year

Job Details

Skills

Cloud Computing
Technical Drafting
System Documentation
Lifecycle Management
GAMP
URS
Software Requirements Specification
FRS
RTM
Acceptance Testing
IQ
OQ
PQ
Risk Assessment
Reporting
Documentation
Testing
Corrective And Preventive Action
IT Service Management
Computer Science
Manufacturing
Good Manufacturing Practice
Data Integrity
SaaS
PaaS
IaaS
Computerized System Validation
GxP
Regulatory Compliance
Management
Quality Management
Change Control
Network
Communication
Microsoft Office
Microsoft Excel
Motivation
Mentorship
LIMS
Master Control
SAP
Element Management System
EMS
IT Infrastructure

Cloud Computing
Technical Drafting
System Documentation
Lifecycle Management
GAMP
URS
Software Requirements Specification
FRS
RTM
Acceptance Testing
IQ
OQ
PQ
Risk Assessment
Reporting
Documentation
Testing
Corrective And Preventive Action
IT Service Management
Computer Science
Manufacturing
Good Manufacturing Practice
Data Integrity
SaaS
PaaS
IaaS
Computerized System Validation
GxP
Regulatory Compliance
Management
Quality Management
Change Control
Network
Communication
Microsoft Office
Microsoft Excel
Motivation
Mentorship
LIMS
Master Control
SAP
Element Management System
EMS
IT Infrastructure

Summary

Provide CSV and CSA-based compliance guidance to the IT function, system owners, and business stakeholders, applying a risk-based approach focused on patient safety, product quality, and data integrity.
Lead the development, harmonization, implementation, and adherence to CSV and CSA procedures, ensuring validation effort is commensurate with system risk, intended use, and GxP impact.
Generate/Revise/Execute system life cycle deliverables using a risk-based CSA methodology and GAMP 5 guidelines (including URS, SRS, FRS, DDS, RTM, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Risk Assessments and Final Validation Summary Report as applicable)
Evaluate proposed new computerized systems and software to determine GxP impact, system criticality, and intended use, and define a CSA aligned validation strategy that balances compliance, efficiency, and business needs.
Review and assess vendor supplied documentation and testing evidence, leveraging supplier activities where appropriate, and perform independent risk-based verification to ensure compliance with internal requirements and regulatory expectations.
Support change control activities, deviation resolution, CAPA, and effectiveness checks for computer systems.
Manage and execute decommissioning activities for retired or end of life systems.
Ensure that suppliers of IT services and solutions are properly assessed to determine their level of compliance and ensure that appropriate controls are in place based on risk

Education & Experience :

Bachelor's degree in Engineering, Computer Science or related discipline.
Must have 3-5+ years of CSV experience in an FDA regulated industry.
Strong knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA 21 CFR Part 11and EU Annex 11 regulations and standards.
Understanding of data integrity requirements and how to perform assessments.
Knowledge and experience with qualifying on premises and externally hosted (SaaS, PaaS, IaaS) software systems.
Ability to work with and influence people at all levels in matters related to CSV,CSA and GxP compliance.
Demonstrated experience in successfully managing complex validation projects and maintaining validation requirements and timelines.
Understanding of quality systems such as change control and discrepancy investigations.
Experience working with IT for qualification of network and infrastructure.
Demonstrated written and verbal communication skills.
Proficient with Microsoft Office, particularly Word and Excel.
High degree of initiative and self-motivation.
Experience creating technical, written content.
Ability to mentor team members and colleagues.
Experience with systems like LabWare LIMS, MasterControl, SAP, Blue Mountain, Environmental Monitoring Systems (EMS), and IT infrastructure components.

Dice Id: 91116760
Position Id: 2560b2de28b5f850f07a91139c07d03a
Posted 3 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 Engineer (Analyst II)

Cambridge, Massachusetts

•

3d ago

Full-time

Computer Systems Validation Engineer

Boston, Massachusetts

•

Today

Full-time

USD 75,000.00 - 106,000.00 per year

CSV Validation Engineer

Boston, Massachusetts

•

3d ago

Full-time

CSV Systems Engineer III

Hopkinton, Massachusetts

•

Today

Full-time

USD 122,800.00 - 145,300.00 per year