CSV Engineer
Somerset, NJ · On-site
Katalyst CRO is a company focused on providing services in the life sciences sector, and they are seeking an IT CSV Validation Engineer. This role is responsible for authoring and executing ...
CSV Engineer
Somerset, NJ · On-site
Katalyst CRO is a company focused on providing services in the life sciences sector, and they are seeking an IT CSV Validation Engineer. This role is responsible for authoring and executing ...
CSV Engineer
Somerset, NJ · On-site
Katalyst CRO is seeking an IT CSV Validation Engineer responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role ...
CSV Engineer
Somerset, NJ · On-site
Katalyst CRO is seeking an IT CSV Validation Engineer responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role ...
CSV Engineer
Raritan, NJ · On-site
CSV Engineer Location: Raritan, NJ(Hybrid) Mandatory - Validation experience with ERP applications / SAP / MES * Experience in validating ERP/SAP/ MES Manufacturing applications * 3+ years ...
Quick apply
CSV Engineer
Raritan, NJ · On-site
CSV Engineer Location: Raritan, NJ(Hybrid) Mandatory - Validation experience with ERP applications / SAP / MES * Experience in validating ERP/SAP/ MES Manufacturing applications * 3+ years ...
CSV Engineer
Raritan, NJ · On-site
$105K - $138K/yr
Lead end-to-end CSV activities (inventory assessment remediation disposition) * Support business separation for large GxP systems * Define & implement risk-based validation strategies * Review ...
CSV Engineer
Raritan, NJ · On-site
$105K - $138K/yr
Lead end-to-end CSV activities (inventory assessment remediation disposition) * Support business separation for large GxP systems * Define & implement risk-based validation strategies * Review ...
0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant Please contact Amanda Mazza, [email protected] Job Overview: We are seeking an experienced CSV Engineer to support the ...
0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant Please contact Amanda Mazza, [email protected] Job Overview: We are seeking an experienced CSV Engineer to support the ...
0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant Please contact Amanda Mazza, amanda@tworivercp.com Job Overview: We are seeking an experienced CSV Engineer to support the ...
Quick apply
0065V6421 CSV Engineer (Laboratory)/Validation Engineer 2 Consultant Please contact Amanda Mazza, amanda@tworivercp.com Job Overview: We are seeking an experienced CSV Engineer to support the ...
S. without sponsorship, now or in the future Position Summary We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including ...
S. without sponsorship, now or in the future Position Summary We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including ...
S. without sponsorship, now or in the future Position Summary We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including ...
S. without sponsorship, now or in the future Position Summary We are seeking an experienced CSV Engineer to support validation activities across a broad portfolio of regulated systems, including ...
Sr. CSV/CQV Specialist
Raritan, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
This role will require CSV and engineering experience, ownership and leadership, ability to work independently, drive effective communication, coordination and collaboration across relevant cross ...
Sr. CSV/CQV Specialist
Raritan, NJ · On-site
Medical
Dental
Vision
Life
Retirement
PTO
This role will require CSV and engineering experience, ownership and leadership, ability to work independently, drive effective communication, coordination and collaboration across relevant cross ...
This role will require CSV and engineering experience, ownership and leadership, ability to work independently, drive effective communication, coordination and collaboration across relevant cross ...
This role will require CSV and engineering experience, ownership and leadership, ability to work independently, drive effective communication, coordination and collaboration across relevant cross ...
CSV Consultant
Raritan, NJ · On-site
$48 - $53/hr
Medical
Dental
Vision
Life
Retirement
Pay Range: $48hr - $53hr Requirement/Must Have: 5+ years of Computer System Validation (CSV ... We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and ...
CSV Consultant
Raritan, NJ · On-site
$48 - $53/hr
Medical
Dental
Vision
Life
Retirement
Pay Range: $48hr - $53hr Requirement/Must Have: 5+ years of Computer System Validation (CSV ... We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and ...
CSV Consultant
Raritan, NJ · On-site
$48 - $53/hr
Medical
Dental
Vision
Life
Retirement
Pay Range: $48hr - $53hr Requirement/Must Have: * 5+ years of Computer System Validation (CSV ... We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and ...
Quick apply
CSV Consultant
Raritan, NJ · On-site
$48 - $53/hr
Medical
Dental
Vision
Life
Retirement
Pay Range: $48hr - $53hr Requirement/Must Have: * 5+ years of Computer System Validation (CSV ... We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and ...
Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager
Raritan, NJ · On-site
Retirement
PTO
... Engineering or another related field is required. Experience and Skills: Required: * 8-10 years of ... Direct experience in CSV Quality and/or CSV for R&D systems * Thorough knowledge of cGMP ...
New
Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager
Raritan, NJ · On-site
Retirement
PTO
... Engineering or another related field is required. Experience and Skills: Required: * 8-10 years of ... Direct experience in CSV Quality and/or CSV for R&D systems * Thorough knowledge of cGMP ...
New
(Sr.) Validation Engineer
Pennington, NJ · On-site
$80K - $120K/yr
Support facility, utility, equipment, process, cleaning, and computer system validation (CSV ... Coordinate validation activities with Manufacturing, Engineering, QA, QC, Automation, and external ...
(Sr.) Validation Engineer
Pennington, NJ · On-site
$80K - $120K/yr
Support facility, utility, equipment, process, cleaning, and computer system validation (CSV ... Coordinate validation activities with Manufacturing, Engineering, QA, QC, Automation, and external ...
Tableau Senior Developer
Princeton, NJ · On-site
The CSV data file is only 5 GB in size, but running aggregations on it is taking quite a bit of ... We are in need of a Tableau developer that can run some basis statistics for us on these data files ...
Tableau Senior Developer
Princeton, NJ · On-site
The CSV data file is only 5 GB in size, but running aggregations on it is taking quite a bit of ... We are in need of a Tableau developer that can run some basis statistics for us on these data files ...
... Engineering or another related field is required. Experience and Skills: Required: * 8-10 years of ... Direct experience in CSV Quality and/or CSV for R&D systems * Thorough knowledge of cGMP ...
New
... Engineering or another related field is required. Experience and Skills: Required: * 8-10 years of ... Direct experience in CSV Quality and/or CSV for R&D systems * Thorough knowledge of cGMP ...
New
The CSV data file is only 5 GB in size, but running aggregations on it is taking quite a bit of ... We are in need of a Tableau developer that can run some basis statistics for us on these data files ...
The CSV data file is only 5 GB in size, but running aggregations on it is taking quite a bit of ... We are in need of a Tableau developer that can run some basis statistics for us on these data files ...
Manager, IT Validation Services
Princeton, NJ · On-site
$90K - $109K/yr
Medical
Dental
Vision
Life
Retirement
PTO
Leads and manages Computer System Validation (CSV) efforts for enterprise GxP systems used across ... Cell Therapy, Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is ...
Manager, IT Validation Services
Princeton, NJ · On-site
$90K - $109K/yr
Medical
Dental
Vision
Life
Retirement
PTO
Leads and manages Computer System Validation (CSV) efforts for enterprise GxP systems used across ... Cell Therapy, Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is ...
(Sr.) Validation Engineer
Pennington, NJ · On-site
$80K - $120K/yr
Medical
Dental
Vision
Life
Retirement
PTO
Support facility, utility, equipment, process, cleaning, and computer system validation (CSV ... Coordinate validation activities with Manufacturing, Engineering, QA, QC, Automation, and external ...
(Sr.) Validation Engineer
Pennington, NJ · On-site
$80K - $120K/yr
Medical
Dental
Vision
Life
Retirement
PTO
Support facility, utility, equipment, process, cleaning, and computer system validation (CSV ... Coordinate validation activities with Manufacturing, Engineering, QA, QC, Automation, and external ...
Manager, IT Validation Services
$90K - $109K/yr
Medical
Dental
Vision
Life
Retirement
PTO
Leads and manages Computer System Validation (CSV) efforts for enterprise GxP systems used across ... Cell Therapy, Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is ...
Manager, IT Validation Services
$90K - $109K/yr
Medical
Dental
Vision
Life
Retirement
PTO
Leads and manages Computer System Validation (CSV) efforts for enterprise GxP systems used across ... Cell Therapy, Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is ...
Csv Engineer information
What is a CSV engineer?
A CSV (Computer System Validation) Engineer is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, comply with regulatory requirements. They develop validation protocols, perform testing, document results, and ensure adherence to industry standards like FDA 21 CFR Part 11 and GAMP 5. Their goal is to confirm that software and hardware systems function correctly, maintain data integrity, and meet compliance requirements.
What are the key skills and qualifications needed to thrive as a CSV engineer?
To thrive as a CSV Engineer (Computer System Validation Engineer), you need a solid understanding of validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a relevant degree in life sciences, engineering, or information technology. Familiarity with validation lifecycle documentation, risk assessment tools, and industry-standard systems like SAP, LIMS, and TrackWise is highly valued, as are certifications such as GAMP or Six Sigma. Strong attention to detail, analytical thinking, and excellent communication skills help CSV Engineers collaborate efficiently with cross-functional teams and ensure thorough documentation. These skills are crucial to guarantee that computerized systems in regulated industries meet compliance requirements, supporting product quality and patient safety.
What are the common challenges faced by a CSV engineer in the pharmaceutical or medical device industry?
CSV Engineers in the pharmaceutical or medical device industry often face the challenge of keeping up with evolving regulatory requirements and ensuring all computerized systems remain compliant throughout their lifecycle. Managing comprehensive documentation, coordinating with multiple departments, and troubleshooting complex system changes can add to the workload. Successful CSV Engineers are proactive about staying informed of regulatory updates, are highly organized, and collaborate closely with Quality Assurance, IT, and operations teams. This dynamic environment offers the opportunity to learn continuously, develop expertise in validation best practices, and advance into leadership or specialized quality roles.
How much do CSV engineers make?
CSV engineers typically earn a salary ranging from $70,000 to $120,000 annually, depending on experience, location, and industry. They often work with data processing tools and scripting languages like Python or SQL to manage and analyze CSV data efficiently.
How to become a CSV engineer?
To become a CSV engineer, you should develop strong skills in data management, scripting languages like Python or SQL, and familiarity with CSV file formats. Earning relevant certifications or degrees in data science, computer science, or related fields can also enhance your qualifications, along with experience working with data processing tools and environments.
What cities near Raritan, NJ are hiring for Csv Engineer jobs?
Cities near Raritan, NJ with the most Csv Engineer job openings:
Full-time
Re-posted 27 days ago
Job description
Job Summary:
Katalyst CRO is a company focused on providing services in the life sciences sector, and they are seeking an IT CSV Validation Engineer. This role is responsible for authoring and executing validation test scripts for regulated systems, ensuring compliance with regulatory requirements and data integrity standards in GxP environments.
Responsibilities:
• Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems
• Support validation activities for ERP Master Data Governance processes, ensuring data accuracy, integrity, and compliance
• Perform validation of Data Lake platforms and associated system interfaces, including data ingestion, transformation, and reporting layers
• Collaborate with cross-functional teams (IT, QA, Business, Data Engineering) to define validation scope, risk assessments, and acceptance criteria
• Ensure compliance with GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle
• Support deviation investigations, CAPAs, and change control activities related to validated systems
• Maintain validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Summary Reports
Qualifications:
Required:
• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline
• 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences environments
• Strong experience with test script authoring and execution for GxP systems
• Experience supporting Master Data Governance processes
• Experience validating Data Lake environments and system interfaces
• Strong understanding of GxP, 21 CFR Part 11, and data integrity principles
• Ability to work independently and manage multiple validation activities with minimal oversight
Preferred:
• SAP experience preferred but not required
• Snowflake experience preferred
• Familiarity with AI/advanced data platforms is a plus
• Experience with validation management tools such as Val Genesis is a plus
Company:
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. Founded in , the company is headquartered in South Plainfield, USA, with a team of 51-200 employees. The company is currently Growth Stage.
Katalyst CRO is a company focused on providing services in the life sciences sector, and they are seeking an IT CSV Validation Engineer. This role is responsible for authoring and executing validation test scripts for regulated systems, ensuring compliance with regulatory requirements and data integrity standards in GxP environments.
Responsibilities:
• Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems
• Support validation activities for ERP Master Data Governance processes, ensuring data accuracy, integrity, and compliance
• Perform validation of Data Lake platforms and associated system interfaces, including data ingestion, transformation, and reporting layers
• Collaborate with cross-functional teams (IT, QA, Business, Data Engineering) to define validation scope, risk assessments, and acceptance criteria
• Ensure compliance with GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle
• Support deviation investigations, CAPAs, and change control activities related to validated systems
• Maintain validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Summary Reports
Qualifications:
Required:
• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related discipline
• 5+ years of Computer System Validation (CSV) experience in pharmaceutical or life sciences environments
• Strong experience with test script authoring and execution for GxP systems
• Experience supporting Master Data Governance processes
• Experience validating Data Lake environments and system interfaces
• Strong understanding of GxP, 21 CFR Part 11, and data integrity principles
• Ability to work independently and manage multiple validation activities with minimal oversight
Preferred:
• SAP experience preferred but not required
• Snowflake experience preferred
• Familiarity with AI/advanced data platforms is a plus
• Experience with validation management tools such as Val Genesis is a plus
Company:
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. Founded in , the company is headquartered in South Plainfield, USA, with a team of 51-200 employees. The company is currently Growth Stage.