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CSV Engineer

Katalyst Healthcares and Lifesciences

Cincinnati, Ohio • Today

Full-time

Data Engineer

Booz Allen Hamilton

Remote • Today

Full-time

USD 99,000.00 - 225,000.00 per year

Remote Senior Data Engineer

Kforce Technology Staffing

Remote or Carlsbad, California • Today

Full-time

$140,000 - $170,000 annually

Job Details

Skills

Manufacturing Operations
Inspection
URS
DirectShow
DS
IQ
OQ
PQ
Information Management
HPLC
PCR
Enterprise Resource Planning
NetSuite
Risk Assessment
Testing
Auditing
Change Control
Regulatory Compliance
Collaboration
Quality Assurance
Computer Science
Life Sciences
Computerized System Validation
GxP
Pharmaceutics
Medical Devices
GAMP
Data Integrity
Veeva
QMS
Instrumentation
Management
Technical Writing
Supervision
Analytical Skill

Manufacturing Operations
Inspection
URS
DirectShow
DS
IQ
OQ
PQ
Information Management
HPLC
PCR
Enterprise Resource Planning
NetSuite
Risk Assessment
Testing
Auditing
Change Control
Regulatory Compliance
Collaboration
Quality Assurance
Computer Science
Life Sciences
Computerized System Validation
GxP
Pharmaceutics
Medical Devices
GAMP
Data Integrity
Veeva
QMS
Instrumentation
Management
Technical Writing
Supervision
Analytical Skill

Summary

Job Description:

The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5).
This role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client.
By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.

Roles & Responsibilities:

uthor, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.
Support computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc.), ERP System (NetSuite).
Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.
Manage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge's quality system.
Collaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining a validated state.

Requirements:

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).
5-7+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
Experience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (Client) like Metasys.
Strong technical writing skills and ability to execute protocols with minimal supervision.
Nice to have: BMRAM and analytical lab instruments experience.

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: 9debec6251b586ba594f9cd48a4c6dc3
Posted 30+ days ago

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Similar Jobs

CSV Engineer

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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

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Sr. Validation Engineer

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Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. As a Validation Engineer, you will play a critical role in ensuring our pharmaceutical manufacturing systems and processes meet rigorous regulatory and quality standards. You will lead and execute validation activities-including equipment, utilities, facilities, and process validations-to ensure our operations remain compliant and inspection-ready. Your expertise in

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CSV Engineer

Columbus, Ohio

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Job Summary: The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). This role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client. By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring

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Engineer Pharma Validation

Remote

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Today

Job Summary Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Assist in authoring and executing protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results within a controlled environment. Responsible for managing and or performing reval

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USD 73,000.00 - 110,000.00 per year

Job Details

Skills

Manufacturing Operations
Inspection
URS
DirectShow
DS
IQ
OQ
PQ
Information Management
HPLC
PCR
Enterprise Resource Planning
NetSuite
Risk Assessment
Testing
Auditing
Change Control
Regulatory Compliance
Collaboration
Quality Assurance
Computer Science
Life Sciences
Computerized System Validation
GxP
Pharmaceutics
Medical Devices
GAMP
Data Integrity
Veeva
QMS
Instrumentation
Management
Technical Writing
Supervision
Analytical Skill

Manufacturing Operations
Inspection
URS
DirectShow
DS
IQ
OQ
PQ
Information Management
HPLC
PCR
Enterprise Resource Planning
NetSuite
Risk Assessment
Testing
Auditing
Change Control
Regulatory Compliance
Collaboration
Quality Assurance
Computer Science
Life Sciences
Computerized System Validation
GxP
Pharmaceutics
Medical Devices
GAMP
Data Integrity
Veeva
QMS
Instrumentation
Management
Technical Writing
Supervision
Analytical Skill

Summary

Job Description:

The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5).
This role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client.
By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.

Roles & Responsibilities:

uthor, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.
Support computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc.), ERP System (NetSuite).
Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.
Manage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge's quality system.
Collaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining a validated state.

Requirements:

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).
5-7+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
Experience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (Client) like Metasys.
Strong technical writing skills and ability to execute protocols with minimal supervision.
Nice to have: BMRAM and analytical lab instruments experience.

Dice Id: 91116760
Position Id: 9debec6251b586ba594f9cd48a4c6dc3
Posted 30+ days ago

Fitment

Dice Job Match Score™

📋 Comparing job requirements...

Create job alert

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Similar Jobs

CSV Engineer

New Jersey

•

Today

Full-time

Sr. Validation Engineer

Lexington, Kentucky

•

Today

Full-time

CSV Engineer

Columbus, Ohio

•

Today

Full-time

Engineer Pharma Validation

Remote

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Full-time

USD 73,000.00 - 110,000.00 per year