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Senior CSV Engineer

Katalyst Healthcares and Lifesciences

Boulder, Colorado • Today

Full-time

Sr. Data Engineer

INSPYR Solutions

Remote • 24d ago

Easy Apply

Contract

$90 - $100

Senior Data Engineer

Machinify

Remote • Today

Full-time

USD 180,000.00 - 220,000.00 per year

Sr. Encompass Developer

Dminds Solutions Inc.

Remote • 3d ago

Easy Apply

Contract, Third Party

Depends on Experience

Data Engineer III

SelectQuote Insurance Services

Remote • Today

Full-time

USD 115,000.00 per year

Senior Automation Engineer

Katalyst Healthcares and Lifesciences

Remote or New Jersey • Today

Full-time

Job Details

Skills

Biotechnology
Manufacturing
URS
DS
DirectShow
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
DS
DirectShow
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: 6b8df3537e232d0e91fe5963f86a0ccb
Posted 2 days ago

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Senior Validation Engineer

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Joining the PHC Group means becoming a vital player in one of the world's foremost producers and suppliers of top-tier laboratory equipment. Operating in the dynamic biomedical and diagnostics sectors, we cater to a diverse and expanding range of life science facilities. Our products are essential tools for researchers and professionals in pharmaceuticals, biotechnology, and healthcare, making a meaningful impact on advancements in these fields. Your role with us will be an integral part of this

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Job Details

Skills

Biotechnology
Manufacturing
URS
DS
DirectShow
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
DS
DirectShow
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: 6b8df3537e232d0e91fe5963f86a0ccb
Posted 2 days ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

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Similar Jobs

CSV and Validation Engineer

New Jersey

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Computer Systems Validation Engineer

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Senior Validation Engineer

Illinois

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USD 85,000.00 - 95,000.00 per year