Computer System Validation (CSV) Engineer Locations: Piscataway, NJ | Chicago, IL Work Arrangement: Onsite Employment Type: Full-Time Experience: 5+ Years of CSV Experience in a GxP-Regulated ...
Computer System Validation (CSV) Engineer Locations: Piscataway, NJ | Chicago, IL Work Arrangement: Onsite Employment Type: Full-Time Experience: 5+ Years of CSV Experience in a GxP-Regulated ...
Collaborate with architecture, hardware, firmware, software, and platform engineering teams to define validation requirements, identify coverage gaps, and improve overall product quality. * Lead ...
Collaborate with architecture, hardware, firmware, software, and platform engineering teams to define validation requirements, identify coverage gaps, and improve overall product quality. * Lead ...
AI Validation and Test Engineer
Secaucus, NJ · On-site
$119K/yr
You are passionate about mentoring engineers and elevating engineering excellence across the organization. KEY RESPONSIBILITIES * Lead system-level, rack-level, and cluster-scale validation strategy ...
AI Validation and Test Engineer
Secaucus, NJ · On-site
$119K/yr
You are passionate about mentoring engineers and elevating engineering excellence across the organization. KEY RESPONSIBILITIES * Lead system-level, rack-level, and cluster-scale validation strategy ...
Computer System Validation (CSV) Engineer
Piscataway, NJ · On-site
$65 - $75/hr
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 ...
Computer System Validation (CSV) Engineer
Piscataway, NJ · On-site
$65 - $75/hr
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 ...
Hardware Validation & Lab Operations Engineer
New York, NY · On-site
$120K - $130K/yr
... Engineering, or related technical field 3-5+ years of experience in a hardware test lab or validation environment Skills & Competencies Proficiency in mechanical and electrical fixture/test station ...
Hardware Validation & Lab Operations Engineer
New York, NY · On-site
$120K - $130K/yr
... Engineering, or related technical field 3-5+ years of experience in a hardware test lab or validation environment Skills & Competencies Proficiency in mechanical and electrical fixture/test station ...
Hardware Validation & Lab Operations Engineer
$120K - $130K/yr
... Engineering, or related technical field 3-5+ years of experience in a hardware test lab or validation environment Skills & Competencies Proficiency in mechanical and electrical fixture/test station ...
Hardware Validation & Lab Operations Engineer
$120K - $130K/yr
... Engineering, or related technical field 3-5+ years of experience in a hardware test lab or validation environment Skills & Competencies Proficiency in mechanical and electrical fixture/test station ...
Hardware Validation & Lab Operations Engineer
New York, NY · On-site
$120K - $130K/yr
... Engineering, or related technical field 3-5+ years of experience in a hardware test lab or validation environment Skills & Competencies Proficiency in mechanical and electrical fixture/test station ...
Hardware Validation & Lab Operations Engineer
New York, NY · On-site
$120K - $130K/yr
... Engineering, or related technical field 3-5+ years of experience in a hardware test lab or validation environment Skills & Competencies Proficiency in mechanical and electrical fixture/test station ...
Validation Lead
Raritan, NJ · On-site
$50 - $55/hr
Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and ... We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and ...
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Validation Lead
Raritan, NJ · On-site
$50 - $55/hr
Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and ... We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and ...
Director, Model Validation
New York, NY · Hybrid
$150K - $261K/yr
Compares validation results with model developer results for replicability. * Measures the effectiveness of validation and monitoring framework; recommends changes as required. * Identifies ...
Director, Model Validation
New York, NY · Hybrid
$150K - $261K/yr
Compares validation results with model developer results for replicability. * Measures the effectiveness of validation and monitoring framework; recommends changes as required. * Identifies ...
Model Validation Expert
New York, NY · On-site
... Engineering, Product, Quants, and Risk Advisors to strengthen model development standards and ... validation standards, methodologies, and best practices Stay at the forefront of regulatory ...
Model Validation Expert
New York, NY · On-site
... Engineering, Product, Quants, and Risk Advisors to strengthen model development standards and ... validation standards, methodologies, and best practices Stay at the forefront of regulatory ...
CSV Engineer
Somerset, NJ · On-site
... Engineer ... This role is responsible for authoring and executing validation test scripts for regulated systems ...
CSV Engineer
Somerset, NJ · On-site
... Engineer ... This role is responsible for authoring and executing validation test scripts for regulated systems ...
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 ...
Mandatory Skills 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs, test ...
Mandatory Skills 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs, test ...
Mandatory Skills • 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs ...
Mandatory Skills • 7+ years of Lab Systems (& lab instrumentation) validation experience is required; with 7+ years of other CSV experience (with extensive experience authoring requirement specs ...
Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications . * Validate systems including LIMS, SAP, CMMS/calibration platforms , and other ...
Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications . * Validate systems including LIMS, SAP, CMMS/calibration platforms , and other ...
Partner with RF Engineering to help drive best-in-class RF network design to achieve the performance objectives. * Continue to provide the best network in the industry as measured by RootMetrics and ...
Partner with RF Engineering to help drive best-in-class RF network design to achieve the performance objectives. * Continue to provide the best network in the industry as measured by RootMetrics and ...
Validation Tester
Farmingdale, NY · On-site
Validation Tester Location: Farmingdale, NY Key Responsibilities • Execute validation testing for electronic records systems per §11.10 (accuracy, audit trails, data integrity) • Validate ...
Validation Tester
Farmingdale, NY · On-site
Validation Tester Location: Farmingdale, NY Key Responsibilities • Execute validation testing for electronic records systems per §11.10 (accuracy, audit trails, data integrity) • Validate ...
Validation Lead
Raritan, NJ · On-site
Validation Lead Location: Raritan, NJ(Hybrid) Duration: 6+ Months Must Have - Computer System Validation Experience M&A related Data Migration and related infrastructure qualification in data ...
Validation Lead
Raritan, NJ · On-site
Validation Lead Location: Raritan, NJ(Hybrid) Duration: 6+ Months Must Have - Computer System Validation Experience M&A related Data Migration and related infrastructure qualification in data ...
Work with the model owner, model developer, and model user on all aspects of model validation and issue resolution. * Prepare model validation and review presentations to the Model Risk Governance ...
Work with the model owner, model developer, and model user on all aspects of model validation and issue resolution. * Prepare model validation and review presentations to the Model Risk Governance ...
Work with the model owner, model developer, and model user on all aspects of model validation and issue resolution. * Prepare model validation and review presentations to the Model Risk Governance ...
Work with the model owner, model developer, and model user on all aspects of model validation and issue resolution. * Prepare model validation and review presentations to the Model Risk Governance ...
Validation Engineer information
See New York salary details
$24.72 - $30.24
2% of jobs
$30.24 - $35.77
6% of jobs
$35.77 - $41.29
13% of jobs
$43.02 is the 25th percentile. Wages below this are outliers.
$41.29 - $46.81
13% of jobs
$46.81 - $52.33
11% of jobs
The median wage is $55.10 / hr.
$52.33 - $57.86
12% of jobs
$57.86 - $63.38
9% of jobs
$67.64 is the 75th percentile. Wages above this are outliers.
$63.38 - $68.90
13% of jobs
$68.90 - $74.43
13% of jobs
$74.43 - $79.95
6% of jobs
$79.95 - $85.47
3% of jobs
$24
$56
$85
How much do validation engineer jobs pay per hour?
What is a validation engineer?
A validation engineer is responsible for testing equipment and electrical systems used in the manufacturing process. As a validation engineer, your primary duty is to work with the other members of the validation team to ensure that these systems measure up to company and industry standards. Skills needed for a validation engineer job include the ability to accurately test, measure, and calibrate manufacturing equipment for maximum efficiency and quality.
What are the key skills and qualifications needed to thrive as a validation engineer, and why are they important?
What are some common challenges validation engineers face when working cross-functionally with other departments?
What is the difference between Validation Engineer vs Quality Assurance Engineer?
| Aspect | Validation Engineer | Quality Assurance Engineer |
|---|---|---|
| Certifications | GMP, ISO, Six Sigma | ISO, Six Sigma, CQA |
| Work Environment | Regulated industries like pharma, biotech, medical devices | Manufacturing, software, and product development |
| Primary Focus | Ensuring products meet specifications through validation processes | Preventing defects through process and system improvements |
| Common Usage | Regulatory compliance, validation protocols | Process audits, quality systems |
Validation Engineers focus on verifying that products and processes meet regulatory standards through validation protocols, especially in regulated industries. Quality Assurance Engineers concentrate on maintaining overall product quality by implementing and auditing quality systems. While both roles aim to ensure product safety and efficacy, Validation Engineers are more involved in validation activities, whereas QA Engineers focus on process improvement and defect prevention.
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What degree do you need to be a validation engineer?
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Job description
Title : Computer System Validation (CSV) Engineer
Locations: Piscataway, NJ | Chicago, IL
Work Arrangement: Onsite
Employment Type: Full-Time
Experience: 5+ Years of CSV Experience in a GxP-Regulated Environment
We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, manufacturing and engineering equipment, and enterprise applications.
The CSV Engineer will work closely with Quality, IT, Laboratory, and Manufacturing teams to ensure computerized systems remain validated and compliant with GxP, 21 CFR Part 11, EU Annex 11, and applicable EMA requirements.
This is an onsite position reporting to the Sr. Director of IT. The successful candidate will have strong hands-on experience developing and executing CSV deliverables within a regulated life sciences environment.
Key Responsibilities- Plan, author, review, and execute CSV deliverables, including:
- Validation Plans
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Design Specifications (DS)
- IQ/OQ/PQ protocols
- Traceability Matrices
- Validation Summary Reports (VSR)
- Perform CSV activities for:
- Laboratory instruments such as HPLC, spectrophotometers, and balances
- Engineering and manufacturing equipment
- LIMS platforms
- SAP systems
- CMMS/calibration systems such as BMRAM
- Partner with System Owners, QA, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state.
- Support change control, periodic reviews, and validation lifecycle activities.
- Conduct computerized system risk assessments and data integrity assessments in alignment with ALCOA+ principles.
- Support audits, regulatory inspections, CAPA investigations, deviations, and compliance activities related to computerized systems.
- Collaborate with senior validation leads and subject matter experts to establish and maintain consistent CSV practices across sites.
- Ensure validation documentation meets applicable regulatory and quality standards.
- Bachelor's degree in Life Sciences, Engineering, Information Technology, or a related field, or equivalent laboratory experience within a life sciences environment.
- Minimum 5 years of Computer System Validation (CSV) experience in a GxP-regulated environment.
- Strong working knowledge of:
- 21 CFR Part 11
- EU Annex 11
- EMA guidance
- GxP compliance requirements
- Hands-on experience authoring and executing IQ/OQ/PQ protocols.
- Familiarity with GAMP 5 principles.
- Experience with risk-based validation methodologies.
- Exposure to Caliber LIMS.
- Experience with SAP QM, MM, or PP in a GxP environment.
- Experience with BMRAM or comparable CMMS/calibration systems.
- Experience working as a liaison between IT, Quality, Laboratory, and Manufacturing teams.
- Strong understanding of computerized system lifecycle management and data integrity principles.