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CSV Engineer

Katalyst Healthcares and Lifesciences

South Bend, Indiana • Yesterday

Full-time

CSV (Computer System Validation) Lead

NexInfo Solutions, Inc.

Remote • Today

Easy Apply

Contract, Third Party

80 - 85

Computer Systems Validation Engineer

Praxis Precision Medicines

Remote • Today

Full-time

USD 150,000.00 - 178,000.00 per year

Lead Clinical Data Engineer

Yale University

Remote or Connecticut • Today

Full-time

USD 90,000.00 - 165,750.00 per year

Senior Data Engineer

Machinify

Remote • Today

Full-time

USD 180,000.00 - 220,000.00 per year

Remote Senior Data Engineer

Kforce Technology Staffing

Remote or Carlsbad, California • Today

Full-time

$140,000 - $170,000 annually

Data Engineer

INflow Federal

Remote or Arlington, Virginia • Today

Full-time

USD 70,000.00 - 90,000.00 per year

Job Details

Skills

FOCUS
Pharmaceutics
Biotechnology
Risk Assessment
Testing
Documentation
Data Integrity
GMP
Computerized System Validation
Quality Assurance
Manufacturing

Summary

Job Description:

Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment.
The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require.
Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, document test results, investigate discrepancies, and work cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners.
Candidates should be comfortable supporting multiple validation workstreams and working independently in a fast-moving project environment.

Qualifications:

pproximately 5-10 years of validation experience within pharmaceutical, biotechnology, biopharmaceutical, or another GMP-regulated environment.
Strong Computer System Validation experience.
Experience supporting validation of GMP computerized systems.
Working knowledge of the CSV lifecycle, including validation planning, requirements, risk assessment, testing/protocol execution, traceability, and validation documentation.
Understanding of data integrity and GMP expectations for computerized systems.
Equipment validation / CQV experience in addition to CSV.
bility to execute established validation protocols and clearly document results.
Experience investigating and documenting validation discrepancies or execution issues.
bility to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
ValGensis is a plus.

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: 74f3cf1063162b057a896c24b20221c8
Posted 30+ days ago

Fitment

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Similar Jobs

CSV Engineer

Chicago, Illinois

•

Today

Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East

Full-time

CSV / Automation Consultant

No location provided

•

Today

Location: Massachusetts (Relocation Required/Accepted) Duration: 5-6 Months Start Date: November 2, 2026 Industry: Pharmaceutical / Life Sciences Client: Pharma-related Rate: $50/hr on W2 Visa: / Mode of Interview: Skype PV: Oxford Global Job Description We are looking for an experienced CSV / Automation Consultant with a strong background in the pharmaceutical or life sciences industry to support a 5-6-month project in Massachusetts. The ideal candidate will have hands-on experience w

Easy Apply

Full-time, Part-time, Contract, Third Party

CSV and Validation Engineer

New Jersey

•

Yesterday

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument s

Full-time

Validation SME

Remote

•

2d ago

Validation SME- Remote Job Summary We are looking for an experienced Validation Subject Matter Expert (SME) with strong knowledge of pharmaceutical and life sciences validation processes, regulatory compliance, and quality systems. The candidate will provide technical expertise and leadership for validation activities across manufacturing, laboratory, utilities, and computerized systems. Key Responsibilities Lead and provide SME support for validation and qualification activities. Develop and

Full-time, Third Party

Depends on Experience

Job Details

Skills

FOCUS
Pharmaceutics
Biotechnology
Risk Assessment
Testing
Documentation
Data Integrity
GMP
Computerized System Validation
Quality Assurance
Manufacturing

Summary

Job Description:

Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment.
The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require.
Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, document test results, investigate discrepancies, and work cross-functionally with Engineering, Quality, Manufacturing, Automation, IT, and system owners.
Candidates should be comfortable supporting multiple validation workstreams and working independently in a fast-moving project environment.

Qualifications:

pproximately 5-10 years of validation experience within pharmaceutical, biotechnology, biopharmaceutical, or another GMP-regulated environment.
Strong Computer System Validation experience.
Experience supporting validation of GMP computerized systems.
Working knowledge of the CSV lifecycle, including validation planning, requirements, risk assessment, testing/protocol execution, traceability, and validation documentation.
Understanding of data integrity and GMP expectations for computerized systems.
Equipment validation / CQV experience in addition to CSV.
bility to execute established validation protocols and clearly document results.
Experience investigating and documenting validation discrepancies or execution issues.
bility to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
ValGensis is a plus.

Dice Id: 91116760
Position Id: 74f3cf1063162b057a896c24b20221c8
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

CSV Engineer

Chicago, Illinois

•

Today

Full-time

CSV / Automation Consultant

No location provided

•

Today

Easy Apply

Full-time, Part-time, Contract, Third Party

CSV and Validation Engineer

New Jersey

•

Yesterday

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Validation SME

Remote

•

2d ago

Full-time, Third Party

Depends on Experience