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Process Validation Engineer

Katalyst Healthcares and Lifesciences

New Haven, Connecticut • Today

Full-time

Sr. Computer Systems Validation Engineer

CooperCompanies

Trumbull, Connecticut • Today

Full-time

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

Arthrex

Remote • Today

Full-time

To define

Sr AI Validation Engineer with Infiniband Fabrics and GPU Infrastructure

Cloud Destinations LLC

Remote • 3d ago

Easy Apply

Contract, Third Party

$80 - $90

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

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

Cybersecurity Validation and Test Engineer

Amyx Inc

Remote • Today

Full-time

USD 100,000.00 - 140,000.00 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

Validation Lead-Remote

Yochana IT Solutions

Remote or Raritan, New Jersey • Today

Easy Apply

Contract

Validation Automation Engineer

Intellectt INC

North Haven, Connecticut • Today

Easy Apply

Contract

$$45/hr

CSV Validation Lead

Nityo Infotech Corporation

Remote • 3d ago

Easy Apply

Contract

Depends on Experience

AML/TF Model Validation Consultant

ISite Technologies Inc

Remote • 4d ago

Easy Apply

Contract, Third Party

Depends on Experience

Job Details

Skills

GMP
FOCUS
Project Delivery
Inspection
Project Implementation
Risk Assessment
Regulatory Compliance
Technical Support
Process Improvement
Continuous Improvement
Life Sciences
Pharmaceutics
Technology Transfer
Manufacturing
Media
Technical Writing
Communication
Collaboration
Good Manufacturing Practice

Summary

Job Description:
We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance.
Responsibilities:

Develop and execute process validation strategies for new and existing sterile manufacturing processes.
Lead Process Performance Qualification (PPQ) activities for pre-filled syringe (PFS) fill lines.
Support technology transfer projects, ensuring seamless implementation of manufacturing processes across production lines.
Coordinate and evaluate aseptic media fill studies to verify process performance and compliance.
Perform process revalidation activities and maintain validated manufacturing processes.
Support smoke studies and qualification activities for automated visual inspection systems.
Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners throughout project execution.
Prepare and review validation protocols, reports, risk assessments, and technical documentation.
Ensure compliance with cGMP , FDA regulations, and industry best practices.
Provide technical support for investigations, process improvements, and continuous improvement initiatives.

Requirements:

Bachelor's degree in Engineering, Life Sciences, or a related discipline.
Experience in Process Validation within a pharmaceutical or sterile manufacturing environment.
Hands-on experience with Technology Transfer and PPQ execution.
Strong knowledge of aseptic manufacturing, media fills, and sterile processing.
Experience supporting smoke studies and qualification activities.
Excellent technical writing, communication, and cross-functional collaboration skills.
Working knowledge of FDA regulations, cGMP, and validation lifecycle requirements.

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: f74d9eaf14e2c42f16643a29b680419d
Posted 10 days ago

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Validation Automation Engineer

North Haven, Connecticut

•

Today

Job Summary Seeking a Validation Automation Engineer with strong Validation Engineering and Manufacturing Engineering experience in a regulated manufacturing environment. The role requires hands-on experience with automation equipment, manufacturing processes, and equipment/system validation. The engineer will support equipment and process validation, qualification, commissioning, troubleshooting, and implementation while maintaining required quality and validation documentation. Responsibiliti

Easy Apply

Contract

$$45/hr

Process Validation Engineer

Newark, New Jersey

•

Today

Job Description: We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance. Respon

Full-time

Validation Engineer

West Greenwich, Rhode Island

•

2d ago

Career Category Operations Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients eac

Full-time

USD 85,878.05 - 116,187.95 per year

Validation Engineer

Springfield, Massachusetts

•

Today

Job Description: Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. The ideal candidate will have direct validation engineering or CQV experience in a fast-paced GMP environment, with strong exposure to fill line qualificat

Full-time

Job Details

Skills

GMP
FOCUS
Project Delivery
Inspection
Project Implementation
Risk Assessment
Regulatory Compliance
Technical Support
Process Improvement
Continuous Improvement
Life Sciences
Pharmaceutics
Technology Transfer
Manufacturing
Media
Technical Writing
Communication
Collaboration
Good Manufacturing Practice

Summary

Develop and execute process validation strategies for new and existing sterile manufacturing processes.
Lead Process Performance Qualification (PPQ) activities for pre-filled syringe (PFS) fill lines.
Support technology transfer projects, ensuring seamless implementation of manufacturing processes across production lines.
Coordinate and evaluate aseptic media fill studies to verify process performance and compliance.
Perform process revalidation activities and maintain validated manufacturing processes.
Support smoke studies and qualification activities for automated visual inspection systems.
Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners throughout project execution.
Prepare and review validation protocols, reports, risk assessments, and technical documentation.
Ensure compliance with cGMP , FDA regulations, and industry best practices.
Provide technical support for investigations, process improvements, and continuous improvement initiatives.

Requirements:

Bachelor's degree in Engineering, Life Sciences, or a related discipline.
Experience in Process Validation within a pharmaceutical or sterile manufacturing environment.
Hands-on experience with Technology Transfer and PPQ execution.
Strong knowledge of aseptic manufacturing, media fills, and sterile processing.
Experience supporting smoke studies and qualification activities.
Excellent technical writing, communication, and cross-functional collaboration skills.
Working knowledge of FDA regulations, cGMP, and validation lifecycle requirements.

Dice Id: 91116760
Position Id: f74d9eaf14e2c42f16643a29b680419d
Posted 10 days ago

Fitment

Dice Job Match Score™

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Similar Jobs

Validation Automation Engineer

North Haven, Connecticut

•

Today

Easy Apply

Contract

$$45/hr

Process Validation Engineer

Newark, New Jersey

•

Today

Full-time

Validation Engineer

West Greenwich, Rhode Island

•

2d ago

Full-time

USD 85,878.05 - 116,187.95 per year

Validation Engineer

Springfield, Massachusetts

•

Today

Full-time