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Senior CSV Engineer

Katalyst Healthcares and Lifesciences

Albany, New York • Today

Full-time

Sr. Data Engineer

INSPYR Solutions

Remote • 17d ago

Easy Apply

Contract

$90 - $100

Clinical Data Ingestion Senior Manager

Siro Clinpharm Pvt Ltd

Remote • 30+d ago

Easy Apply

Full-time, Third Party

Depends on Experience

Senior Data Engineer ( W2 Role)

NGTalentTech Group LLC

Remote • 2d ago

Easy Apply

Contract

Depends on Experience

Sr. Encompass Developer

Dminds Solutions Inc.

Remote • 2d ago

Easy Apply

Third Party, Contract

Depends on Experience

Senior Automation Engineer

Katalyst Healthcares and Lifesciences

Remote or New Jersey • Today

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.
Ability 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.
Ability 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: 9c443a1dda671099f5516d8e5ac262f5
Posted 8 days ago

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Dice Job Match Score™

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CSV Engineer

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Job Description: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer

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Third Party, Contract

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Engineer Pharma Validation

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Job Summary Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Assist in authoring and executing protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results within a controlled environment. Responsible for managing and or performing reval

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Senior Engineer, Process Validation

Remote

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Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Aldevron, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the spee

Full-time

USD 100,000.00 - 130,000.00 per year

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.
Ability 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.
Ability to manage multiple validation projects simultaneously.
High attention to detail and regulatory compliance mindset.

Dice Id: 91116760
Position Id: 9c443a1dda671099f5516d8e5ac262f5
Posted 8 days ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

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Similar Jobs

CSV Engineer

New Jersey

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Today

Full-time

POMS Techno functional SME

Albany, New York

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25d ago

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Engineer Pharma Validation

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USD 73,000.00 - 110,000.00 per year

Senior Engineer, Process Validation

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USD 100,000.00 - 130,000.00 per year