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 ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Computer System Validation Engineer 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 engineer jobs pay per hour?
What are some common challenges faced by Computer System Validation Engineers in regulated industries?
What does a computer system validation engineer do?
What are the key skills and qualifications needed to thrive as a Computer System Validation Engineer, and why are they important?
What is the difference between Computer System Validation Engineer vs Quality Assurance Specialist?
| Aspect | Computer System Validation Engineer | Quality Assurance Specialist |
|---|---|---|
| Certifications | GAMP, GxP validation certifications | ISO, Six Sigma, GMP certifications |
| Work Environment | Pharmaceutical, biotech, medical device industries | Manufacturing, software, healthcare sectors |
| Primary Focus | Validating computer systems and software compliance | Ensuring overall quality and process improvements |
The Computer System Validation Engineer primarily focuses on validating computer systems to meet regulatory standards, ensuring software compliance in regulated industries. In contrast, the Quality Assurance Specialist oversees broader quality processes, including audits and process improvements. Both roles require knowledge of industry regulations but differ in scope and specific responsibilities.
What is the salary of SoC validation engineer?
What is the salary of a CSV engineer?
Is computer system validation a good field?

Full-time
Posted 3 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