Search Jobs | Dice.com

15 results (0 new)

Group by company

CSV Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts • 16d ago

Full-time

CSV Systems Engineer III

Curia, Inc.

Hopkinton, Massachusetts • Today

Full-time

USD 122,800.00 - 145,300.00 per year

CSV Engineer

Katalyst Healthcares and Lifesciences

Woburn, Massachusetts • 16d ago

Full-time

Computer System Validation (CSV) Lead - Oracle Fusion

Algo Soft Solutions LLC

Boston, Massachusetts • 4d ago

Easy Apply

Full-time

55 - 60

Lead Data Engineer

Flagship Pioneering, Inc.

Cambridge, Massachusetts • Today

Full-time

USD 128,000.00 - 176,000.00 per year

Sr Computer Systems Validation Expert (CSV)

SUPERSEVA GLOBAL SERVICES LLC

Norwood, Massachusetts • 4d ago

Easy Apply

Contract

Depends on Experience

Computer Systems Validation Engineer

CAI

Boston, Massachusetts • Today

Full-time

USD 75,000.00 - 106,000.00 per year

Data Migration Engineer

RadNet

Somerville, Massachusetts • Today

Full-time

USD 90,000.00 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

Sr. Computer Systems Validation Engineer

CooperCompanies

Remote or Trumbull, Connecticut • Today

Full-time

Data Engineer II

SelectQuote Insurance Services

Remote • Today

Full-time

USD 95,000.00 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

Validation Engineer

Katalyst Healthcares and Lifesciences

Waltham, Massachusetts • 16d ago

Full-time

Validation Engineer

Katalyst Healthcares and Lifesciences

Cambridge, Massachusetts • 16d ago

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 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 Systems Engineer III

Hopkinton, Massachusetts

•

Today

Job Description CSV Systems Engineer in Hopkinton, MA Build your future at Curia, where our work has the power to save lives. The CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the necessary tools to provide quality metrics, measurements, and reports for internal audits and inspections. Curia is a g

Full-time

USD 122,800.00 - 145,300.00 per year

Computer Systems Validation Engineer

Boston, Massachusetts

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our Foundational Principles: - W

Full-time

USD 75,000.00 - 106,000.00 per year

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

Engineer III, Validation

Plainville, Massachusetts

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 5 Commerce Blvd, Plainville, MA 02762 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform validation activities that include drafting, executing, reviewing, and approving quality documentation (User Requirement Specifications (URS), Commissioning protocols, IOQs, PQs, Re-qualifications, Periodic Reviews, Final Reports, Valid

Full-time

USD 134,202.00 - 138,900.00 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:

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 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 Systems Engineer III

Hopkinton, Massachusetts

•

Today

Full-time

USD 122,800.00 - 145,300.00 per year

Computer Systems Validation Engineer

Boston, Massachusetts

•

Today

Full-time

USD 75,000.00 - 106,000.00 per year

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

Waltham, Massachusetts

•

Today

Full-time

USD 110,000.00 - 126,000.00 per year

Engineer III, Validation

Plainville, Massachusetts

•

Today

Full-time

USD 134,202.00 - 138,900.00 per year