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Senior Validation Engineer Jobs in Edison, NJ (NOW HIRING)

Regulatory & Financial Risk - Senior Manager - Model Validation Our Deloitte Regulatory, Risk ... Expert understanding of AI best practices and sound engineering judgment for complex issues.

Requirements Include: BS in a science or engineering field or equivalent experience 8-12 years ... We provide commissioning, qualification, validation, start-up, project management and other ...

Senior Validation Project Manager

Princeton, NJ ยท On-site

$102K - $111K/yr

Requirements Include: BS in a science or engineering field or equivalent experience 8-12 years ... We provide commissioning, qualification, validation, start-up, project management and other ...

Senior Validation Project Manager

Princeton, NJ ยท On-site

$102K - $111K/yr

Requirements Include: BS in a science or engineering field or equivalent experience 8-12 years ... We provide commissioning, qualification, validation, start-up, project management and other ...

Requirements Include: BS in a science or engineering field or equivalent experience 8-12 years ... We provide commissioning, qualification, validation, start-up, project management and other ...

Requirements Include: BS in a science or engineering field or equivalent experience 8-12 years ... We provide commissioning, qualification, validation, start-up, project management and other ...

This is a senior technical role with a primary focus on ESG Scoring and ESG analytics models. You ... Engineering, Product, Quants, and Risk Advisors to strengthen model development standards and ...

Showing results 21-40

Senior Validation Engineer information

See Edison, NJ salary details

$35

$65

$100

How much do senior validation engineer jobs pay per hour?

As of Sep 8, 2026, the average hourly pay for senior validation engineer in Edison, NJ is $65.69, according to ZipRecruiter salary data. Most workers in this role earn between $52.40 and $74.62 per hour, depending on experience, location, and employer.

What does a senior validation engineer do?

A Senior Validation Engineer is responsible for ensuring that products, systems, or processes meet regulatory standards and function as intended. They develop and execute validation protocols, analyze test data, and document results to confirm compliance with industry and company standards. Senior Validation Engineers often lead validation projects, collaborate with cross-functional teams, and mentor junior staff. Their work is critical in industries like pharmaceuticals, biotechnology, and manufacturing, where product safety and efficacy are essential.

What are the key skills and qualifications needed to thrive as a senior validation engineer, and why are they important?

To thrive as a Senior Validation Engineer, you need a solid background in engineering, quality assurance, and regulatory compliance, typically supported by a relevant degree and experience in validation within regulated industries. Familiarity with validation protocols (IQ, OQ, PQ), statistical analysis tools, and systems like FDA 21 CFR Part 11 is crucial. Strong problem-solving, attention to detail, and effective communication skills help ensure successful project outcomes and cross-functional collaboration. These skills and qualifications are essential to maintain product quality, meet regulatory standards, and drive continuous improvement.

What are some typical challenges faced by senior validation engineers when leading validation projects?

Senior Validation Engineers often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and coordinating cross-functional teams. Balancing the needs of production, quality assurance, and regulatory affairs requires strong communication and project management skills. Additionally, troubleshooting unexpected validation failures and documenting results thoroughly are key aspects that demand both technical expertise and attention to detail.

What is the difference between Senior Validation Engineer vs Validation Specialist?

AspectSenior Validation EngineerValidation Specialist
CredentialsBachelor's or Master's in Engineering, Life Sciences, or related fields; often with certifications like GxP or CSVSimilar educational background; certifications like GxP or CSV are common
Work EnvironmentDesigns and oversees validation protocols in manufacturing, biotech, or pharmaceutical settingsExecutes validation tasks, tests, and documentation in similar environments
Employer & IndustryPharmaceutical, biotech, medical device companiesSame industries, often working under validation teams
Search & ComparisonOften compared for experience level and responsibilitiesCommonly searched together for validation roles

The main difference is that a Senior Validation Engineer typically leads validation projects, designs protocols, and oversees validation activities, while a Validation Specialist focuses on executing validation tests and documentation. Both roles require similar credentials and work in comparable environments, but the Senior Validation Engineer has more responsibility for planning and oversight.

What are popular job titles related to Senior Validation Engineer jobs in Edison, NJ?

For Senior Validation Engineer jobs in Edison, NJ, the most frequently searched job titles are:

What job categories do people searching Senior Validation Engineer jobs in Edison, NJ look for?

The top searched job categories for Senior Validation Engineer jobs in Edison, NJ are:

What cities near Edison, NJ are hiring for Senior Validation Engineer jobs?

Cities near Edison, NJ with the most Senior Validation Engineer job openings:

Infographic showing various Senior Validation Engineer job openings in Edison, NJ as of August 2026, with employment types broken down into 88% Full Time, 6% Part Time, 1% Temporary, and 5% Contract. Highlights an 86% Physical, 5% Hybrid, and 9% Remote job distribution, with an average salary of $136,630 per year, or $65.7 per hour.

Computer System Validation (CSV) Engineer

Kashiv BioSciences, LLC

Piscataway, NJ โ€ข On-site

$65 - $75/hr

Full-time

Re-posted 7 days ago


Job description

Description


Position Type: Full-time Employee (FTE)

Location: Piscataway, NJ (onsite - physical presence required)

Reports To: Sr. Director of IT

Rate: $65-$75/hour, not overtime eligibleย 

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: ย 

  • 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:ย 

  • 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.