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CQV Validation Engineer - New Albany OH - Onsite

LEO DOES IT INC

New Albany, Ohio • Yesterday

Easy Apply

Contract

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

Columbus, Ohio • Today

Full-time

Sr AI Validation Engineer with Infiniband Fabrics and GPU Infrastructure

Cloud Destinations LLC

Remote • Yesterday

Easy Apply

Third Party, Contract

$80 - $90

Validation Lead-Remote

Yochana IT Solutions

Remote or Raritan, New Jersey • Today

Easy Apply

Contract

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

Arthrex

Remote • Today

Full-time

To define

Integration Validation Engineer- VHA DSO

HigherEchelon

Remote • Today

Full-time

Computer Systems Validation Engineer

Praxis Precision Medicines

Remote • Today

Full-time

USD 150,000.00 - 178,000.00 per year

Staff Systems Engineer - Release Strategy & Validation

Torc Robotics

Remote or Ann Arbor, Michigan • Today

Full-time

USD 168,800.00 - 202,600.00 per year

CQV Engineer

Katalyst Healthcares and Lifesciences

Remote or New Jersey • Today

Full-time

Sr. Engineer, Cleaning Validation

HIKMA PHARMACEUTICAL

Columbus, Ohio • 9d ago

Full-time

CSV Validation Lead

Nityo Infotech Corporation

Remote • Yesterday

Easy Apply

Contract

Depends on Experience

AML/TF Model Validation Consultant

ISite Technologies Inc

Remote • 2d ago

Easy Apply

Contract, Third Party

Depends on Experience

Cybersecurity Validation and Test Engineer

Amyx Inc

Remote • Today

Full-time

USD 100,000.00 - 140,000.00 per year

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

Job Details

Skills

Summary

Job Title: CQV Validation Engineer
Location: New Albany OH

Onsite

Duration: 06 Months

Description

Top 3 Must Have Skill Sets:

Demonstrated experience leading Commissioning, Qualification, and Validation (CQV) activities within a GMP-regulated biotechnology or pharmaceutical manufacturing environment, with direct experience supporting packaging equipment, combination products, and/or device assembly processes.
Hands-on experience using electronic quality and document management systems, including KNEAT, Veeva, TrackWise, or equivalent platforms for managing validation documentation, change controls, deviations, CAPAs, and quality records.
Ability and willingness to be onsite and support manufacturing operations during off-shift hours, including weekday and weekend night shifts, as required to execute validation activities, and support commercial manufacturing schedules.
The Senior Validation Process Development Engineer serves as a technical leader responsible for supporting commercial GMP manufacturing operations while driving the development, characterization, optimization, and validation of automated and semi-automated combination product assembly and packaging processes.
This role applies advanced engineering principles to ensure robust, compliant, and efficient manufacturing processes that support both commercial production and new product introduction.
The engineer provides day-to-day technical support for commercial manufacturing through equipment and process troubleshooting, critical process parameter assessment and optimization, process performance monitoring, deviation investigations, root cause analysis, and implementation of continuous improvement initiatives to enhance product quality, process capability, and operational excellence.
Key documentation responsibilities include authoring, executing, and/or approving technical documentation, including:
Characterization test protocols and reports Commissioning, Qualification, and Validation (CQV) test protocols and reports for manufacturing equipment, computerized systems, and processes Engineering studies and technical assessments.
Validation Master Plans, Validation Plans, and Summary Reports.
Technical reports supporting equipment lifecycle management, process improvements, technology transfers, and new product introductions (NPI)
Working cross-functionally with Manufacturing, Quality, Validation, Engineering and other technical organizations, the Senior Engineer leads complex engineering initiatives, resolves technical challenges, and identifies opportunities to improve equipment reliability, process performance, and manufacturing capability. This individual serves as a Subject Matter Expert (SME) for combination products, device assembly technologies, and GMP manufacturing processes, ensuring compliance with regulatory requirements while supporting the successful commercialization and lifecycle management of the business's product portfolio.

Basic Qualifications

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

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: 91130524
Position Id: 2026-538
Posted 3 days ago

Fitment

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Lead Validation Engineer II

Wilmington, Ohio

•

Today

Alkermes, Inc. Lead Validation Engineer Il Wilmington, OH Responsibilities: Serve as subject matter expert in & lead equipment, facility, & utility qualification for clinical & commercial pharmaceutical manufacturing & laboratory systems. Serve as technical lead for maintenance of GMP compliance through monitoring, review, assessment & qualification of activities. Ensure Validation systems (policies, procedures, reviews, VMPs) effectively meet current/changing industry demands. Salary: $135,0

Full-time

USD 135,000.00 - 150,000.00 per year

Tech Transfer/ Process Engineer III

Massachusetts

•

Today

Pay Rate Low: 80 | Pay Rate High: 100 Our client is a leading life sciences company that develops and manufactures tools and materials used in the production of biologic drugs. They are looking for a skilled Tech Transfer/Process Engineer to join their growing team in Middlesex County, MA! This is a great opportunity to contribute to an innovative life science organization! Location: Middlesex County, MA Pay rate: $80 - $100/hr. DOE Job type: 6-month contract (possibility of extension or hire)

Full-time

USD 80.00 per hour

Engineer, Facilties

Maryland

•

Today

Engineer, Facilities About Site Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately

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Senior Process Engineer - Equipment

Maryland

•

Today

Senior Process Engineer - Equipment About Site Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at

Full-time

USD 94,000.00 - 128,000.00 per year

Job Details

Skills

Summary

Job Title: CQV Validation Engineer
Location: New Albany OH

Onsite

Duration: 06 Months

Description

Top 3 Must Have Skill Sets:

Demonstrated experience leading Commissioning, Qualification, and Validation (CQV) activities within a GMP-regulated biotechnology or pharmaceutical manufacturing environment, with direct experience supporting packaging equipment, combination products, and/or device assembly processes.
Hands-on experience using electronic quality and document management systems, including KNEAT, Veeva, TrackWise, or equivalent platforms for managing validation documentation, change controls, deviations, CAPAs, and quality records.
Ability and willingness to be onsite and support manufacturing operations during off-shift hours, including weekday and weekend night shifts, as required to execute validation activities, and support commercial manufacturing schedules.
The Senior Validation Process Development Engineer serves as a technical leader responsible for supporting commercial GMP manufacturing operations while driving the development, characterization, optimization, and validation of automated and semi-automated combination product assembly and packaging processes.
This role applies advanced engineering principles to ensure robust, compliant, and efficient manufacturing processes that support both commercial production and new product introduction.
The engineer provides day-to-day technical support for commercial manufacturing through equipment and process troubleshooting, critical process parameter assessment and optimization, process performance monitoring, deviation investigations, root cause analysis, and implementation of continuous improvement initiatives to enhance product quality, process capability, and operational excellence.
Key documentation responsibilities include authoring, executing, and/or approving technical documentation, including:
Characterization test protocols and reports Commissioning, Qualification, and Validation (CQV) test protocols and reports for manufacturing equipment, computerized systems, and processes Engineering studies and technical assessments.
Validation Master Plans, Validation Plans, and Summary Reports.
Technical reports supporting equipment lifecycle management, process improvements, technology transfers, and new product introductions (NPI)
Working cross-functionally with Manufacturing, Quality, Validation, Engineering and other technical organizations, the Senior Engineer leads complex engineering initiatives, resolves technical challenges, and identifies opportunities to improve equipment reliability, process performance, and manufacturing capability. This individual serves as a Subject Matter Expert (SME) for combination products, device assembly technologies, and GMP manufacturing processes, ensuring compliance with regulatory requirements while supporting the successful commercialization and lifecycle management of the business's product portfolio.

Basic Qualifications

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Dice Id: 91130524
Position Id: 2026-538
Posted 3 days ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Create job alert

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

Similar Jobs

Lead Validation Engineer II

Wilmington, Ohio

•

Today

Full-time

USD 135,000.00 - 150,000.00 per year

Tech Transfer/ Process Engineer III

Massachusetts

•

Today

Full-time

USD 80.00 per hour

Engineer, Facilties

Maryland

•

Today

Full-time

USD 80,000.00 - 110,000.00 per year

Senior Process Engineer - Equipment

Maryland

•

Today

Full-time

USD 94,000.00 - 128,000.00 per year