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CSV Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts • Today

Full-time

CSV Engineer

Katalyst Healthcares and Lifesciences

Woburn, Massachusetts • Today

Full-time

Junior Validation Engineer with CSV / CQV

Arthur Lawrence

Cambridge, Massachusetts • 14d ago

Easy Apply

Contract, Third Party

$30 - $39

Data Migration Engineer

RadNet

Somerville, Massachusetts • Today

Full-time

USD 100,000.00 per year

SIEM Data Engineer

State Street Corporation

Quincy, Massachusetts • Today

Full-time

USD 90,000.00 - 157,500.00 per year

SIEM Data Engineer

State Street Corporation

Quincy, Massachusetts • Today

Full-time

USD 90,000.00 - 157,500.00 per year

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Alkermes, Inc

Waltham, Massachusetts • Today

Full-time

USD 110,000.00 - 126,000.00 per year

Remote Senior Data Engineer

Kforce Technology Staffing

Remote or Carlsbad, California • Today

Full-time

$140,000 - $170,000 annually

Validation Engineer

Katalyst Healthcares and Lifesciences

Waltham, Massachusetts • Today

Full-time

Validation Engineer

Katalyst Healthcares and Lifesciences

Cambridge, Massachusetts • Today

Full-time

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:

Approximately 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.
Ability to execute established validation protocols and clearly document results.
Experience investigating and documenting validation discrepancies or execution issues.
Ability 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: f6ba687dda7baf9069691f29a8467f35
Posted 1 hour ago

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Similar Jobs

CSV Engineer

Woburn, Massachusetts

•

Today

Job Summary: 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 S

Full-time

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Waltham, Massachusetts

•

Today

Job Description This position provides leadership and accountability for Digital Quality across the organization's Quality, Regulatory, and R&D systems landscape, with responsibility for supporting computer system validation activities in alignment with applicable regulatory expectations, internal procedures, and data integrity requirements. The role is focused on ensuring GxP computerized systems are implemented, maintained, and governed in a compliant, risk-based, and inspection-ready manner

Full-time

USD 110,000.00 - 126,000.00 per year

Junior Validation Engineer with CSV / CQV

Cambridge, Massachusetts

•

14d ago

Arthur Lawrence is looking for a Junior Validation Engineer with CSV / CQV one our clients in Cambridge MA. Please find the job description below and send us your updated resume if interested: Must-Have Skills: Experience performing validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment in compliance with GMP and 21 CFR Part 11 requirements. Hands-on experience supporting Master Validation Plans (MVPs), SOPs, validation protocols, and Process Per

Easy Apply

Contract, Third Party

$30 - $39

Validation Engineer

Boston, Massachusetts

•

Today

Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred. Roles & Responsibilit

Full-time

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:

Approximately 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.
Ability to execute established validation protocols and clearly document results.
Experience investigating and documenting validation discrepancies or execution issues.
Ability to work cross-functionally with Quality, Engineering, Automation, Manufacturing, IT, and system owners.
ValGensis is a plus.

Dice Id: 91116760
Position Id: f6ba687dda7baf9069691f29a8467f35
Posted 1 hour ago

Fitment

Dice Job Match Score™

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Similar Jobs

CSV Engineer

Woburn, Massachusetts

•

Today

Full-time

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Waltham, Massachusetts

•

Today

Full-time

USD 110,000.00 - 126,000.00 per year

Junior Validation Engineer with CSV / CQV

Cambridge, Massachusetts

•

14d ago

Easy Apply

Contract, Third Party

$30 - $39

Validation Engineer

Boston, Massachusetts

•

Today

Full-time