Search Jobs | Dice.com

8 results (1 new)

Group by company

Senior CSV Engineer

Katalyst Healthcares and Lifesciences

Chicago, Illinois • Today

Full-time

CSV Validation Consultant

Compsciprep LLC

Hybrid in Chicago, Illinois • Today

Easy Apply

Contract, Third Party

Depends on Experience

Sr. Data Engineer

INSPYR Solutions

Remote • 5d ago

Easy Apply

Contract

$90 - $100

Clinical Data Ingestion Senior Manager

Siro Clinpharm Pvt Ltd

Remote • 18d ago

Easy Apply

Full-time, Third Party

Depends on Experience

Clinical Data Enablement Senior Manager

Siro Clinpharm Pvt Ltd

Remote or Hybrid in Mexico Beach, Florida • 18d ago

Easy Apply

Full-time

Depends on Experience

Remote Senior Data Engineer

Kforce Technology Staffing

Remote or Carlsbad, California • Today

Full-time

$140,000 - $170,000 annually

Senior Systems Engineer

GliaCell Technologies

Remote or Annapolis, Maryland • Today

Full-time

USD 170,000.00 - 230,000.00 per year

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.
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: c0fb9fb45eeabcd4d054e78d79d4d4cf
Posted 30+ days ago

Fitment

Dice Job Match Score™

🎯 Assessing qualifications...

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

CSV Validation Consultant

Hybrid in Chicago, Illinois

•

Today

Hi, Greetings from CompSciPrepWe have an immediate opening for a position with one of our prestigious clients that may interest you.Below is the job description for your reference. Please go through it and let me know your thoughts so that we can move forward.Job Description:Role: Computer System Validation (CSV) / Validation Consultant Life SciencesLocation: Multiple LocationSummary:We are looking for an experienced Computer System Validation (CSV) Consultant with strong experience in Life Sci

Easy Apply

Contract, Third Party

Depends on Experience

CSV Engineer

New Jersey

•

Today

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

Full-time

Validation Engineer

Round Lake, Illinois

•

Today

Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred. Roles & Responsibilit

Full-time

Senior CQV Engineer/Validation Engineer

No location provided

•

Today

Direct hire /Full time On-site Boulder, CO Salary expectation: You povide Summary We are seeking a highly motivated Senior CQV Engineer to support commissioning, qualification, and validation activities for pharmaceutical and biotechnology manufacturing facilities. The successful candidate will lead and execute CQV deliverables associated with GMP-regulated process equipment, utilities, automation systems, cleanrooms, and manufacturing operations. This role requires hands-on technical expertis

Easy Apply

Full-time

$DOE

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: c0fb9fb45eeabcd4d054e78d79d4d4cf
Posted 30+ days ago

Fitment

Dice Job Match Score™

🎯 Assessing qualifications...

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

CSV Validation Consultant

Hybrid in Chicago, Illinois

•

Today

Easy Apply

Contract, Third Party

Depends on Experience

CSV Engineer

New Jersey

•

Today

Full-time

Validation Engineer

Round Lake, Illinois

•

Today

Full-time

Senior CQV Engineer/Validation Engineer

No location provided

•

Today

Easy Apply

Full-time

$DOE