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11 results (4 new)

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Senior CSV Engineer

Katalyst Healthcares and Lifesciences

St. Louis, Missouri • 2d ago

Full-time

CSV (Computer System Validation) Lead

NexInfo Solutions, Inc.

Remote • Today

Easy Apply

Contract, Third Party

80 - 85

CSV Tester or Validation QA Engineer

Techwave Consulting Inc

Remote • Today

Easy Apply

Third Party, Contract

Depends on Experience

CSV Tester

VYSoft Solutions Inc

Remote • Today

Easy Apply

Contract

60 - 65

Senior Data Engineer

Machinify

Remote • Today

Full-time

USD 180,000.00 - 220,000.00 per year

Senior Data Engineer - Snowflake

iSpace, Inc

Remote • 10d ago

Easy Apply

Contract

$60 - $66

Remote Senior Analytics Engineer - Python/Data Visualization

Motion Recruitment Partners, LLC

Remote • Today

Easy Apply

Contract

USD 40.00 per hour

Lead Clinical Data Engineer

Yale University

Remote or Connecticut • Today

Full-time

USD 90,000.00 - 165,750.00 per year

CSV Tester

Techwave Consulting Inc

Remote • Today

Easy Apply

Contract

Depends on Experience

Remote Senior Data Engineer

Kforce Technology Staffing

Remote or Carlsbad, California • Today

Full-time

$140,000 - $170,000 annually

Senior Automation Engineer

Katalyst Healthcares and Lifesciences

Remote or New Jersey • 2d ago

Full-time

Job Details

Skills

Biotechnology
Manufacturing
URS
DirectShow
DS
ELN
Collaboration
Quality Assurance
System Deployment
Change Control
Mentorship
Continuous Improvement
Computer Science
Life Sciences
GxP
Pharmaceutics
Medical Devices
LIMS
MES
Enterprise Resource Planning
GAMP
IQ
OQ
PQ
Auditing
SAP
Oracle
Veeva
Trackwise
Cloud Computing
SaaS
Data Integrity
Technical Writing
Documentation
Leadership
Computerized System Validation
Analytical Skill
Risk Assessment
Communication
Stakeholder Management
Management
Attention To Detail
Regulatory Compliance

Biotechnology
Manufacturing
URS
DirectShow
DS
ELN
Collaboration
Quality Assurance
System Deployment
Change Control
Mentorship
Continuous Improvement
Computer Science
Life Sciences
GxP
Pharmaceutics
Medical Devices
LIMS
MES
Enterprise Resource Planning
GAMP
IQ
OQ
PQ
Auditing
SAP
Oracle
Veeva
Trackwise
Cloud Computing
SaaS
Data Integrity
Technical Writing
Documentation
Leadership
Computerized System Validation
Analytical Skill
Risk Assessment
Communication
Stakeholder Management
Management
Attention To Detail
Regulatory Compliance

Summary

Job Description:
The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on validation strategy, risk-based approaches, and regulatory compliance across the system lifecycle.
Responsibilities:

Lead and execute computer system validation (CSV) activities for GxP-regulated systems.
Develop and review validation deliverables including validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports.
Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regulations.
Define and implement risk-based validation strategies for computerized systems.
Oversee validation of systems such as LIMS, ELN, MES, ERP, CDS, and laboratory systems.
Support system implementations, upgrades, and decommissioning activities from a validation perspective.
Collaborate with IT, QA, Engineering, and business stakeholders to ensure compliant system deployment.
Lead change control assessments and determine validation impact of system changes.
Ensure data integrity (ALCOA+) compliance across validated systems.
Support audits and regulatory inspections by providing validation documentation and system justification.
Mentor and guide junior CSV engineers and validation team members.
Drive continuous improvement of validation processes, templates, and standards.
Review vendor documentation and ensure systems meet regulatory expectations prior to deployment.

Requirements:

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
5-10+ years of experience in Computer System Validation (CSV) or validation engineering.
Strong experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
Hands-on experience with validation of LIMS, MES, ERP, or laboratory systems.
Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
Experience authoring and executing IQ/OQ/PQ protocols and validation documentation.
Strong understanding of risk-based validation and data integrity principles.
Experience supporting regulatory audits and inspections.

Preferred Skills:

Experience with systems such as LabWare, SAP, Oracle, Veeva, TrackWise, Empower.
Knowledge of cloud-based validation and SaaS systems.
Experience in data integrity remediation projects.
Strong technical writing and documentation skills.
bility to lead cross-functional validation projects.

Key Competencies:

Strong leadership and SME-level expertise in CSV.
Excellent analytical and risk assessment skills.
Strong communication and stakeholder management.
bility to manage multiple validation projects simultaneously.
High attention to detail and regulatory compliance mindset.

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: 778a96dc2ee41e5b3d752b64e97a797f
Posted 30+ days ago

Fitment

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Job Details

Skills

Biotechnology
Manufacturing
URS
DirectShow
DS
ELN
Collaboration
Quality Assurance
System Deployment
Change Control
Mentorship
Continuous Improvement
Computer Science
Life Sciences
GxP
Pharmaceutics
Medical Devices
LIMS
MES
Enterprise Resource Planning
GAMP
IQ
OQ
PQ
Auditing
SAP
Oracle
Veeva
Trackwise
Cloud Computing
SaaS
Data Integrity
Technical Writing
Documentation
Leadership
Computerized System Validation
Analytical Skill
Risk Assessment
Communication
Stakeholder Management
Management
Attention To Detail
Regulatory Compliance

Biotechnology
Manufacturing
URS
DirectShow
DS
ELN
Collaboration
Quality Assurance
System Deployment
Change Control
Mentorship
Continuous Improvement
Computer Science
Life Sciences
GxP
Pharmaceutics
Medical Devices
LIMS
MES
Enterprise Resource Planning
GAMP
IQ
OQ
PQ
Auditing
SAP
Oracle
Veeva
Trackwise
Cloud Computing
SaaS
Data Integrity
Technical Writing
Documentation
Leadership
Computerized System Validation
Analytical Skill
Risk Assessment
Communication
Stakeholder Management
Management
Attention To Detail
Regulatory Compliance

Summary

Lead and execute computer system validation (CSV) activities for GxP-regulated systems.
Develop and review validation deliverables including validation plans, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, and summary reports.
Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and GxP regulations.
Define and implement risk-based validation strategies for computerized systems.
Oversee validation of systems such as LIMS, ELN, MES, ERP, CDS, and laboratory systems.
Support system implementations, upgrades, and decommissioning activities from a validation perspective.
Collaborate with IT, QA, Engineering, and business stakeholders to ensure compliant system deployment.
Lead change control assessments and determine validation impact of system changes.
Ensure data integrity (ALCOA+) compliance across validated systems.
Support audits and regulatory inspections by providing validation documentation and system justification.
Mentor and guide junior CSV engineers and validation team members.
Drive continuous improvement of validation processes, templates, and standards.
Review vendor documentation and ensure systems meet regulatory expectations prior to deployment.

Requirements:

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
5-10+ years of experience in Computer System Validation (CSV) or validation engineering.
Strong experience in GxP-regulated pharmaceutical, biotech, or medical device environments.
Hands-on experience with validation of LIMS, MES, ERP, or laboratory systems.
Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
Experience authoring and executing IQ/OQ/PQ protocols and validation documentation.
Strong understanding of risk-based validation and data integrity principles.
Experience supporting regulatory audits and inspections.

Preferred Skills:

Experience with systems such as LabWare, SAP, Oracle, Veeva, TrackWise, Empower.
Knowledge of cloud-based validation and SaaS systems.
Experience in data integrity remediation projects.
Strong technical writing and documentation skills.
bility to lead cross-functional validation projects.

Key Competencies:

Strong leadership and SME-level expertise in CSV.
Excellent analytical and risk assessment skills.
Strong communication and stakeholder management.
bility to manage multiple validation projects simultaneously.
High attention to detail and regulatory compliance mindset.

Dice Id: 91116760
Position Id: 778a96dc2ee41e5b3d752b64e97a797f
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

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