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CSV Validation Engineer

Katalyst Healthcares and Lifesciences

Jacksonville, Florida • 4d ago

Full-time

Data Validation Engineer

ICF Consulting Group, Inc.

Remote or Reston, Virginia • Today

Full-time

USD 98,614.00 - 167,644.00 per year

Job Details

Skills

URS
DirectShow
DS
IQ
OQ
PQ
Risk Assessment
Change Control
Collaboration
Quality Assurance
Manufacturing
Test Scripts
Corrective And Preventive Action
Regulatory Compliance
System Implementation
Auditing
Computerized System Validation
Pharmaceutics
Medical Devices
GxP
GMP
Data Integrity
Documentation
Communication
Stakeholder Management

Summary

Summary:
We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN.
Roles & Responsibilities:

Develop and execute Computer System Validation (CSV) strategies, plans, protocols, and reports.
Create and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation summary reports.
Perform risk assessments, impact assessments, traceability, and change control activities.
Support validation of GxP-regulated computerized systems in accordance with applicable regulations and company procedures.
Collaborate with QA, IT, Engineering, Manufacturing, and business stakeholders to ensure systems meet intended use and compliance requirements.
Execute and document test scripts, deviations, investigations, and CAPA activities.
Ensure compliance with FDA, GxP, GMP, 21 CFR Part 11, and data integrity requirements.
Support system implementation, upgrades, remediation, periodic reviews, and decommissioning activities.
Participate in audits and provide validation documentation and evidence as required.

Education & Experience:

8 years Experience in Computer System Validation / CSV within pharmaceutical, biotech, medical device, or other regulated environments.
Strong knowledge of GxP, GMP, FDA regulations, 21 CFR Part 11, and data integrity.
Experience with validation methodologies, risk-based validation, and electronic documentation.
Excellent documentation, communication, and stakeholder-management skills.

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: 7a93b631bda396c62f55ef2ab7e76ba6
Posted 5 days ago

Fitment

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Jacksonville, Florida

•

Today

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop

Full-time

CSV and Validation Engineer

New Jersey

•

4d ago

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

SAP Validation

Remote

•

13d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

Easy Apply

Contract

Depends on Experience

Senior Engineer, Validation

Maryland

•

Today

About Site Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., hous

Full-time

USD 120,000.00 - 140,000.00 per year

Job Details

Skills

URS
DirectShow
DS
IQ
OQ
PQ
Risk Assessment
Change Control
Collaboration
Quality Assurance
Manufacturing
Test Scripts
Corrective And Preventive Action
Regulatory Compliance
System Implementation
Auditing
Computerized System Validation
Pharmaceutics
Medical Devices
GxP
GMP
Data Integrity
Documentation
Communication
Stakeholder Management

Summary

Summary:
We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN.
Roles & Responsibilities:

Develop and execute Computer System Validation (CSV) strategies, plans, protocols, and reports.
Create and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation summary reports.
Perform risk assessments, impact assessments, traceability, and change control activities.
Support validation of GxP-regulated computerized systems in accordance with applicable regulations and company procedures.
Collaborate with QA, IT, Engineering, Manufacturing, and business stakeholders to ensure systems meet intended use and compliance requirements.
Execute and document test scripts, deviations, investigations, and CAPA activities.
Ensure compliance with FDA, GxP, GMP, 21 CFR Part 11, and data integrity requirements.
Support system implementation, upgrades, remediation, periodic reviews, and decommissioning activities.
Participate in audits and provide validation documentation and evidence as required.

Education & Experience:

8 years Experience in Computer System Validation / CSV within pharmaceutical, biotech, medical device, or other regulated environments.
Strong knowledge of GxP, GMP, FDA regulations, 21 CFR Part 11, and data integrity.
Experience with validation methodologies, risk-based validation, and electronic documentation.
Excellent documentation, communication, and stakeholder-management skills.

Dice Id: 91116760
Position Id: 7a93b631bda396c62f55ef2ab7e76ba6
Posted 5 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

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Jacksonville, Florida

•

Today

Full-time

CSV and Validation Engineer

New Jersey

•

4d ago

Full-time

SAP Validation

Remote

•

13d ago

Easy Apply

Contract

Depends on Experience

Senior Engineer, Validation

Maryland

•

Today

Full-time

USD 120,000.00 - 140,000.00 per year

CSV Validation Engineer

Skills

Summary

Dice Job Match Score™

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CSV Validation Engineer

Job Details

Skills

Summary

Dice Job Match Score™

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