Search Jobs | Dice.com

6 results (2 new)

Group by company

CSV Engineer

Katalyst Healthcares and Lifesciences

Grand Forks, North Dakota • Today

Full-time

CSV Validation Lead

Nityo Infotech Corporation

Remote • Today

Easy Apply

Contract

Depends on Experience

CSV Lead

Shrive Technologies LLC

Remote • Today

Easy Apply

Contract, 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

Senior Data Engineer

Machinify

Remote • Today

Full-time

USD 180,000.00 - 220,000.00 per year

Data Engineer III

SelectQuote Insurance Services

Remote • 5d ago

Full-time

USD 115,000.00 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: 352a2e992067c4a82c8fdb9ae74036e5
Posted 2 hours 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

CSV Engineer

New Jersey

•

Today

Job Description: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer

Full-time

CSV and Validation Engineer

New Jersey

•

Today

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

Computer Systems Validation Engineer

Remote

•

Today

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role: you'll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.

Full-time

USD 150,000.00 - 178,000.00 per year

Principle Validation Specialist

No location provided

•

Today

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there?s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that?s the kind of work we want to be part of. Lonza has an exciting opportunity for a Sr. Validation Specialist to

Full-time

Compensation information provided in the description

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: 352a2e992067c4a82c8fdb9ae74036e5
Posted 2 hours 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

CSV Engineer

New Jersey

•

Today

Full-time

CSV and Validation Engineer

New Jersey

•

Today

Full-time

Computer Systems Validation Engineer

Remote

•

Today

Full-time

USD 150,000.00 - 178,000.00 per year

Principle Validation Specialist

No location provided

•

Today

Full-time

Compensation information provided in the description