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 ...
CSV Quality Support Lead
Raritan, NJ · On-site
$43 - $55/hr
CSV Quality Support Lead CSI Companies is seeking a CSV Quality Support Lead to lead and execute Computer System Validation (CSV) activities across the system lifecycle. This role requires expertise ...
CSV Quality Support Lead
Raritan, NJ · On-site
$43 - $55/hr
CSV Quality Support Lead CSI Companies is seeking a CSV Quality Support Lead to lead and execute Computer System Validation (CSV) activities across the system lifecycle. This role requires expertise ...
Expertise in Computer System Validation (CSV), Systems Development Life Cycle (SDLC) methodologies and CSV regulations, standards, and best practices * Working knowledge of Computer Software ...
Quick apply
Expertise in Computer System Validation (CSV), Systems Development Life Cycle (SDLC) methodologies and CSV regulations, standards, and best practices * Working knowledge of Computer Software ...
Clinical Systems Quality-III
Woodcliff Lake, NJ · On-site
$53.57 - $55/hr
Essential Functions * Participate in computer systems and vendor audits for review of their ... Minimum 7 years' experience Computerized System Validation (CSV) experience * Minimum 5 years ...
Clinical Systems Quality-III
Woodcliff Lake, NJ · On-site
$53.57 - $55/hr
Essential Functions * Participate in computer systems and vendor audits for review of their ... Minimum 7 years' experience Computerized System Validation (CSV) experience * Minimum 5 years ...
Enterprise Rollout & Validation (CSV) * Partner with global quality business owners to author test scripts and drive Computer Systems Validation (CSV) or Computer Software Assurance (CSA) strategies ...
Enterprise Rollout & Validation (CSV) * Partner with global quality business owners to author test scripts and drive Computer Systems Validation (CSV) or Computer Software Assurance (CSA) strategies ...
Enterprise Rollout & Validation (CSV) * Partner with global quality business owners to author test scripts and drive Computer Systems Validation (CSV) or Computer Software Assurance (CSA) strategies ...
Enterprise Rollout & Validation (CSV) * Partner with global quality business owners to author test scripts and drive Computer Systems Validation (CSV) or Computer Software Assurance (CSA) strategies ...
Clinical Systems Quality-III
Westwood, NJ · On-site
$50 - $55/hr
Participate in computer systems and vendor audits for review of their validation (fit-for-purpose ... Minimum 7 years' experience Computerized System Validation (CSV) experience * Minimum 5 years ...
Quick apply
Clinical Systems Quality-III
Westwood, NJ · On-site
$50 - $55/hr
Participate in computer systems and vendor audits for review of their validation (fit-for-purpose ... Minimum 7 years' experience Computerized System Validation (CSV) experience * Minimum 5 years ...
Engineering Specialist
Millburn, NJ · On-site
... Computer System Validation (CSV) activities. Required Skills & Tools: • Experience with CSV and commissioning activities. • Strong knowledge of deviation investigation and documentation. • ...
Engineering Specialist
Millburn, NJ · On-site
... Computer System Validation (CSV) activities. Required Skills & Tools: • Experience with CSV and commissioning activities. • Strong knowledge of deviation investigation and documentation. • ...
Validation Tester
Farmingdale, NY · On-site
... Computer Systems Validation (CSV) • Deep understanding of FDA regulations, GxP requirements, and data integrity • Experience supporting FDA approval processes and regulatory submissions • ...
Validation Tester
Farmingdale, NY · On-site
... Computer Systems Validation (CSV) • Deep understanding of FDA regulations, GxP requirements, and data integrity • Experience supporting FDA approval processes and regulatory submissions • ...
... CSV) within Life Sciences domain. Responsibilities: • Create, review, and approve validation deliverables • Define IT system development processes (build, test, deploy, monitor) following Agile ...
... CSV) within Life Sciences domain. Responsibilities: • Create, review, and approve validation deliverables • Define IT system development processes (build, test, deploy, monitor) following Agile ...
CSV Engineer
Raritan, NJ · On-site
CSV Engineer Location: Raritan, NJ(Hybrid) Mandatory - Validation experience with ERP applications ... Computer System Validation (Based on the role selected) • Experience in FDA and/or Global ...
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CSV Engineer
Raritan, NJ · On-site
CSV Engineer Location: Raritan, NJ(Hybrid) Mandatory - Validation experience with ERP applications ... Computer System Validation (Based on the role selected) • Experience in FDA and/or Global ...
It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation ...
It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation ...
It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation ...
It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation ...
Sr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible ... Generate or review/update computer system related policies, procedures, templates, forms, etc.
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Sr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible ... Generate or review/update computer system related policies, procedures, templates, forms, etc.
Associate Director Senior Data Analyst (Clinical Sciences)
Berkeley Heights, NJ · On-site +1
$146K - $234K/yr
Coordinate service operations and SLA compliance, support Computer System Validation (CSV) and GxP processes * Maintain validation documentation (URS, IQ/OQ/PQ, traceability, reports) and ensure ...
Associate Director Senior Data Analyst (Clinical Sciences)
Berkeley Heights, NJ · On-site +1
$146K - $234K/yr
Coordinate service operations and SLA compliance, support Computer System Validation (CSV) and GxP processes * Maintain validation documentation (URS, IQ/OQ/PQ, traceability, reports) and ensure ...
System Test and Validation Lead
New York, NY · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
New York, NY · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Jersey City, NJ · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Jersey City, NJ · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Jericho, NY · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Jericho, NY · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Stamford, CT · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
System Test and Validation Lead
Stamford, CT · On-site +1
Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...
Computer System Validation Csv information
See New York salary details
$32.35 - $36.94
4% of jobs
$36.94 - $41.53
18% of jobs
$42.58 is the 25th percentile. Wages below this are outliers.
$41.53 - $46.12
13% of jobs
$46.12 - $50.71
14% of jobs
The median wage is $51.47 / hr.
$50.71 - $55.30
9% of jobs
$55.30 - $59.89
5% of jobs
$59.89 - $64.48
7% of jobs
$64.48 - $69.07
4% of jobs
$69.20 is the 75th percentile. Wages above this are outliers.
$69.07 - $73.66
9% of jobs
$73.66 - $78.25
12% of jobs
$78.25 - $82.84
4% of jobs
$32
$56
$82
How much do computer system validation csv jobs pay per hour?
What are the key skills and qualifications needed to thrive in the Computer System Validation Csv position, and why are they important?
To thrive as a Computer System Validation (CSV) professional, you need a solid understanding of computer science, regulatory compliance (such as FDA 21 CFR Part 11), and validation methodology, often supported by a degree in a scientific or technical field. Familiarity with documentation tools, validation protocols, and quality management systems, as well as certifications like PMP or Six Sigma, is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication skills enable effective cross-functional collaboration. Mastering these skills ensures accurate validation processes, regulatory compliance, and smooth project execution in highly regulated environments.
What is a Computer System Validation (CSV) job?
A Computer System Validation (CSV) job involves ensuring that computerized systems used in regulated industries, such as pharmaceuticals and medical devices, comply with industry standards and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). CSV professionals develop validation protocols, conduct testing, and document system performance to ensure data integrity, reliability, and compliance. Their role is critical in maintaining system quality and avoiding regulatory risks.
What are some typical challenges faced by Computer System Validation professionals and how are they addressed?
Computer System Validation (CSV) professionals often encounter challenges such as keeping up with evolving regulations, managing complex documentation requirements, and ensuring robust communication between IT, quality assurance, and business teams. Navigating system upgrades while maintaining compliance with strict regulatory standards requires careful planning and thorough risk assessment. Successful candidates address these challenges by staying current with industry guidance, utilizing validation templates and checklists, and fostering strong teamwork across various departments. Building collaborative relationships and maintaining meticulous records help ensure both audit readiness and smooth project completion.

Full-time
Posted 24 days ago
Job description
Full-time
Description
Position Type: Full-time Employee (FTE)
Location: Piscataway, NJ (onsite - physical presence required)
Reports To: Sr. Director of IT
Work Authorization: Must be authorized to work in the U.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 laboratory instrumentation, engineering and manufacturing equipment, and enterprise platforms. This role serves as a liaison across Quality, IT, Laboratory, and Manufacturing functions, ensuring systems are validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements.
Essential Duties & Responsibilities
- Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports) across assigned systems
- Support CSV activities across lab instruments (HPLC, GC, spectrophotometers, balances, etc.), engineering and manufacturing equipment, and enterprise systems including Caliber LIMS, SAP, and BMRAM
- Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review
- Execute risk assessments and data integrity assessments aligned with ALCOA+ principles
- Support audits, inspections, CAPA investigations, and deviations related to computerized systems
- Collaborating with senior validation leads and SMEs to drive consistent practices across sites
Requirements
Position Requirements and Qualifications
- Bachelor's degree in Life Sciences, Engineering, or IT; OR equivalent laboratory experience in a life sciences environment
- Minimum 5 years of CSV experience in a GxP-regulated environment
- Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
- Hands-on experience authoring and executing IQ/OQ/PQ protocols
- Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)
Experience:
- Minimum 5 years of CSV experience in a GxP-regulated environment
- Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance
- Hands-on experience authoring and executing IQ/OQ/PQ protocols
- Experience validating at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM)
Specialized Knowledge and Skills:
- Familiarity with GAMP 5 principles and risk-based validation
- Exposure to Caliber LIMS
- Exposure to SAP (QM, MM, PP) in a GxP context
- Experience with BMRAM or equivalent CMMS/calibration systems
- Prior experience acting as a liaison across IT, Quality, Lab, and Manufacturing teams
Work Environment & Physical Demands:
- This is an on-site position
- Must be able to work extended hours or weekend hours, as may be required.
Noise:
- No extraordinary noise levels.
Standing/Lifting:
- Very unlikely, but can be able to lift at least 20 lbs.
Visual:
- No extraordinary requirements.
Stress:
- High-paced demanding environment to meet ambitious project goals.
Travel:
- Moderate domestic travel may be required.
About Kashiv BioSciences
Sourced by ZipRecruiter
Industry
Manufacturing
Company size
201 - 500 Employees
Headquarters location
Piscataway, NJ, US
Year founded
2011