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Validation Engineer II

Katalyst Healthcares and Lifesciences

Houston, Texas • Yesterday

Full-time

Quality Control Engineer II

Motion Recruitment Partners, LLC

Houston, Texas • Today

Easy Apply

Contract

$45 - $52

Verification and Validation Engineer

Axiom Space

Houston, Texas • Today

Full-time

NASA Space Reactor - 1 Freedom Flight Software Verification and Validation (V&V) Test Engineer

CACI International, Inc.

Houston, Texas • Today

Full-time

USD 76,000.00 - 155,700.00 per year

CSA Consultant/Senior Validation Engineer 2

Clevanoo LLC

Remote • 9d ago

Easy Apply

Contract

Depends on Experience

Sr. HPC Deployment and Cable Validation Engineer

Cloud Destinations LLC

Remote • Today

Easy Apply

Contract

70 - 80

Senior Software Systems Engineer, Autonomous Systems Validation Confidence

General Motors

Remote or Sunnyvale, California • Today

Full-time

USD 153,200.00 - 234,100.00 per year

Data Validation Engineer

ICF Consulting Group, Inc.

Remote or Reston, Virginia • Today

Full-time

USD 98,614.00 - 167,644.00 per year

Integration Validation Engineer- VHA DSO

HigherEchelon

Remote • Today

Full-time

Validation SME

Arnex Solutions LLC

Remote • 2d ago

Full-time, Third Party

Depends on Experience

Computer Systems Validation Engineer

Praxis Precision Medicines

Remote • Today

Full-time

USD 150,000.00 - 178,000.00 per year

Cybersecurity Validation and Test Engineer

Amyx Inc

Remote • Today

Full-time

USD 100,000.00 - 140,000.00 per year

Sr. HPC Deployment and Cable Validation Engineer

Cloud Destinations LLC

Remote • Today

Easy Apply

Contract

Up to 80

Test & Validation Integration Engineer - Federal Customer

Dell Technologies

Remote or Maryland • Today

Full-time

Commercial LEO Development Program (CLDP) Integrated Systems Test & Validation/Systems Engineering & Integration (SE&I) Senior Project Engineer

Aerospace Corporation

Remote • Today

Part-time

100% REMOTE: Validation, Compliance & Testing Lead

Parmesoft Inc.

Remote • 9d ago

Easy Apply

Third Party, Contract

Depends on Experience

Senior DevOps Validation Engineer

Keeper Security, Inc.

Remote • Today

Full-time

CSV (Computer System Validation) Lead

NexInfo Solutions, Inc.

Remote • Today

Easy Apply

Contract, Third Party

80 - 85

SAP AI Validation Consultant (Finance / Order to Cash)

Mako Professionals

Remote or Hybrid in Florida • Today

Easy Apply

Third Party, Contract

Sr. Business Systems Analyst - Validation (CSA) Governance & Process Support

Arthrex

Remote • Today

Full-time

To define

Technical Project Manager - SaMD / GxP Validation

Medasource

Remote • Today

Contract

$60.00 - $80.00

Validation Engineer

Katalyst Healthcares and Lifesciences

Houston, Texas • Yesterday

Full-time

Test Engineer II

ASM Research

Remote • Today

Full-time

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

Sterilization Engineer II

Katalyst Healthcares and Lifesciences

Remote or New Jersey • Yesterday

Full-time

Job Details

Skills

Root Cause Analysis
Management
Presentations
Manufacturing
Quality Assurance
Research and Development
Documentation
Continuous Improvement
Chemical Engineering
Biomedical Engineering
Mechanical Engineering
Pharmaceutics
IQ
OQ
PQ
Mapping
Good Manufacturing Practice
Data Analysis
Corrective And Preventive Action
Change Control
Auditing
Communication
Collaboration

Summary

Summary :
We are seeking a Validation Engineer II to support critical validation activities within a pharmaceutical / biopharmaceutical manufacturing environment. The ideal candidate will have hands-on experience in Commissioning, Qualification, and Validation (CQV), including the development and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, facilities, and Controlled Temperature Units.

Roles and Responsibilities :

Develop, review, and execute CQV deliverables for pharmaceutical and biopharmaceutical systems.
Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, facilities, and controlled temperature units.
Lead and support temperature mapping studies for controlled temperature units and temperature-controlled environments.
Ensure validation activities comply with cGMP requirements, ICH guidelines, and FDA regulations.
Analyze validation data, identify trends, and ensure results meet established acceptance criteria.
Investigate validation deviations and support root cause analysis and corrective actions.
Develop, track, and implement Corrective and Preventive Actions (CAPAs).
Manage change controls for validated systems and assess their impact on qualification status.
Prepare validation protocols, reports, and other CQV documentation.
Support internal and external audits by preparing validation records and presenting validation activities when required.
Collaborate with Manufacturing, QA, Engineering, and R&D teams to ensure successful validation execution.
Maintain accurate and compliant validation documentation in accordance with company procedures.
Support continuous improvement of validation processes and maintain the validated state of systems.

Education & Experience :

Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline.
2-6 years of validation engineering experience.
Experience in the pharmaceutical or biopharmaceutical industry.
Hands-on experience developing and executing CQV deliverables.
Strong experience with IQ, OQ, and PQ protocols and execution.
Experience validating equipment, utilities, facilities, and controlled temperature units.
Temperature mapping experience is highly preferred.
Knowledge of cGMP requirements and ICH guidelines.
Understanding of FDA regulations, including 21 CFR Parts 210, 211, and 820.
Experience with validation data analysis and deviation handling.
Familiarity with CAPA and change control processes.
Experience supporting internal and external audits.
Strong cross-functional communication and coordination skills.

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: 29ecc6e3f89358de37a128f94733539b
Posted 30+ days ago

Fitment

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Job Details

Skills

Root Cause Analysis
Management
Presentations
Manufacturing
Quality Assurance
Research and Development
Documentation
Continuous Improvement
Chemical Engineering
Biomedical Engineering
Mechanical Engineering
Pharmaceutics
IQ
OQ
PQ
Mapping
Good Manufacturing Practice
Data Analysis
Corrective And Preventive Action
Change Control
Auditing
Communication
Collaboration

Summary

Develop, review, and execute CQV deliverables for pharmaceutical and biopharmaceutical systems.
Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, facilities, and controlled temperature units.
Lead and support temperature mapping studies for controlled temperature units and temperature-controlled environments.
Ensure validation activities comply with cGMP requirements, ICH guidelines, and FDA regulations.
Analyze validation data, identify trends, and ensure results meet established acceptance criteria.
Investigate validation deviations and support root cause analysis and corrective actions.
Develop, track, and implement Corrective and Preventive Actions (CAPAs).
Manage change controls for validated systems and assess their impact on qualification status.
Prepare validation protocols, reports, and other CQV documentation.
Support internal and external audits by preparing validation records and presenting validation activities when required.
Collaborate with Manufacturing, QA, Engineering, and R&D teams to ensure successful validation execution.
Maintain accurate and compliant validation documentation in accordance with company procedures.
Support continuous improvement of validation processes and maintain the validated state of systems.

Education & Experience :

Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline.
2-6 years of validation engineering experience.
Experience in the pharmaceutical or biopharmaceutical industry.
Hands-on experience developing and executing CQV deliverables.
Strong experience with IQ, OQ, and PQ protocols and execution.
Experience validating equipment, utilities, facilities, and controlled temperature units.
Temperature mapping experience is highly preferred.
Knowledge of cGMP requirements and ICH guidelines.
Understanding of FDA regulations, including 21 CFR Parts 210, 211, and 820.
Experience with validation data analysis and deviation handling.
Familiarity with CAPA and change control processes.
Experience supporting internal and external audits.
Strong cross-functional communication and coordination skills.

Dice Id: 91116760
Position Id: 29ecc6e3f89358de37a128f94733539b
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

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

Similar Jobs

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Sr. Molding Engineer II, Molding & Tooling Engineering

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Cleanroom Engineer

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