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Process Validation Engineer

Katalyst Healthcares and Lifesciences

Harrisburg, Pennsylvania • 3d ago

Full-time

Validation Engineer

CAI

Harrisburg, Pennsylvania • Today

Full-time

USD 72,800.00 - 80,100.00 per year

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

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

Sr. Computer Systems Validation Engineer

CooperCompanies

Remote or Trumbull, Connecticut • Today

Full-time

USD 96,441.00 - 126,000.00 per year

Senior DevOps Validation Engineer

Keeper Security, Inc.

Remote • Today

Full-time

Cybersecurity Validation and Test Engineer

Amyx Inc

Remote • Today

Full-time

USD 100,000.00 - 140,000.00 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

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

SAP Validation

Devfi

Remote • 12d ago

Easy Apply

Contract

Depends on Experience

ETL Developer ( Data migration, Data Validation, SQL, Workday, Peoplesoft ) 15+ years of experience

ACS Consultancy Services, Inc.

Remote or New York, New York • 3d ago

Easy Apply

Full-time

Engineering Manager, Verification and Validation (STATCOM)

GE Vernova

Remote • Today

Full-time

USD 113,200.00 - 188,800.00 per year

Validation Engineer

Katalyst Healthcares and Lifesciences

Harrisburg, Pennsylvania • 3d ago

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

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: 32c0d619753054b8bf62ddbde177b2a1
Posted 30+ days ago

Fitment

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Job Description BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services.From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team's expertise to create a process design for our clients' products that best suits their needs. The Experience With operations spanning the g

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Job Description Responsible for supporting medical devices for both existing and new product development, production, and processes. This includes creating or verifying specifications, maintaining, and enhancing product processes, and designing fixtures and equipment, testing processes, equipment, test methods and raw materials to ensure that the concepts and prototypes meet their specifications. Support projects related to new product introductions, process development engineering, quality sys

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

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.

Dice Id: 91116760
Position Id: 32c0d619753054b8bf62ddbde177b2a1
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.

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