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Computer System Validation Jobs in New Jersey (NOW HIRING)

Noblesoft Technologies

CSV Engineer

Raritan, NJ · On-site

Experience in validating ERP/SAP/ MES Manufacturing applications * 3+ years' experience with System Development Lifecyle 7+ years' experience in Computer System Validation (Based on the role selected)

JS Consulting

... with Computer System Validation and Computer Software Assurance * Aptitude in GAMP 5 and 21 CFR ... Part 11 standards * Previous experience in a GxP industry or a life sciences industry is required

Katalyst CRO

CSV Engineer

Somerset, NJ · On-site

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 ...

Katalyst CRO

CSV Engineer

Somerset, NJ · On-site

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 ...

GenScript/ProBio

(Sr.) Validation Engineer

Hopewell, NJ

$80K - $120K/yr

Support facility, utility, equipment, process, cleaning, and computer system validation (CSV) activities. * Support technology transfer and startup activities for new client manufacturing programs.

GenScript/ProBio

(Sr.) Validation Engineer

Pennington, NJ · On-site

$80K - $120K/yr

Support facility, utility, equipment, process, cleaning, and computer system validation (CSV) activities. * Support technology transfer and startup activities for new client manufacturing programs.

CYNET SYSTEMS

CSV Consultant

Raritan, NJ · On-site

$48 - $53/hr

Pay Range: $48hr - $53hr Requirement/Must Have: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and ...

New

CYNET SYSTEMS

CSV Consultant

Raritan, NJ · On-site

$48 - $53/hr

Pay Range: $48hr - $53hr Requirement/Must Have: * 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and ...

New

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How much do computer system validation jobs pay per hour?

As of Aug 8, 2026, the average hourly pay for computer system validation in New Jersey is $55.15, according to ZipRecruiter salary data. Most workers in this role earn between $42.45 and $65.38 per hour, depending on experience, location, and employer.

What are some typical challenges faced in computer system validation roles?

Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.

What is a computer system validation?

A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.

What are the key skills and qualifications needed to thrive in computer system validation, and why are they important?

To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring software and systems meet compliance standards such as GxP. It involves documentation, testing, and validation of computer systems, often requiring knowledge of regulatory requirements and validation tools. The field offers stable employment opportunities and career growth for professionals with technical skills and certifications like GAMP or 21 CFR Part 11 compliance.
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Computer System Validation jobs near you
Infographic showing various Computer System Validation job openings in New Jersey as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 14% Part Time, 1% Temporary, and 2% Contract. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution, with an average salary of $114,704 per year, or $55.1 per hour.

Quality Assurance Validation Manager

Thermo Fisher Scientific

Teterboro, NJ • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 28 days ago

Thermo Fisher Scientific rating

7.7

Company rating: 7.7 out of 10

Based on 422 frontline employees who took The Breakroom Quiz

196th of 537 rated manufacturers

Job description

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Location: Ridgefield, New Jersey - Sterile Fill-Finish & Packaging Site
Our state-of-the-art sterile fill-finish and packaging facility in Ridgefield, NJ, is dedicated to meeting the growing needs of biotech and pharmaceutical drug developers. With expanded capabilities in pre-filled syringe and liquid vial manufacturing, the site increases U.S. capacity to manufacture the medicines patients rely on every day.
As part of Thermo Fisher Scientific's global network, Ridgefield complements our world-class contract development and manufacturing services and strengthens our sterile fill-finish footprint-now spanning seven sites worldwide, including three in the U.S. (Greenville, NC; Plainville, MA; and Ridgefield, NJ). Strategically located along the East Coast to streamline logistics and attract top talent, the 360,000 sq. ft. Ridgefield site plays a vital role in the global pharmaceutical supply chain, with products distributed to more than 67 countries across all continents.
Join Thermo Fisher Scientific and play a critical role in supporting the delivery of life-changing therapies and products to patients worldwide. As a Quality Assurance Validation Manager, you will lead validation activities that ensure product quality, operational excellence, and compliance with global regulatory requirements. Working in a highly collaborative environment, you will partner with Quality Assurance, Manufacturing, Engineering, Regulatory Affairs, and other cross-functional teams to maintain the validated state of systems and processes that support the manufacture of therapeutics and other critical products.
You'll have the opportunity to influence validation strategy, lead complex projects, and develop a high-performing team while contributing to a culture of quality, continuous improvement, and innovation.
Discover Impactful Work:
As a Quality Assurance Validation Manager, you will provide leadership and oversight for validation programs across equipment, utilities, facilities, computer systems, cleaning processes, analytical instruments, and manufacturing operations. You will ensure validation activities are executed in accordance with cGMP requirements, quality standards, and industry best practices while supporting business objectives, new product introductions, and technology transfer initiatives. In partnership with Quality Assurance and cross-functional teams, you will help maintain compliance and the validated state of critical systems and processes that support the manufacture of therapeutics and other life-changing products.
A Day in the Life:
  • Lead and manage validation activities across manufacturing, laboratory, utility, facility, computerized systems, and analytical instruments
  • Develop and maintain validation strategies, validation master plans, and project timelines
  • Oversee the planning, coordination, execution, review, and approval of validation protocols and reports
  • Partner with project managers and cross-functional stakeholders to establish priorities, monitor progress, and communicate project status
  • Ensure validation activities comply with FDA, EU, and applicable global regulatory requirements and Quality Assurance standards
  • Support equipment qualification, process validation, cleaning validation, utility qualification, computer system validation, and analytical instrument qualification programs
  • Apply risk assessment methodologies and statistical tools to support validation decisions
  • Drive continuous improvement initiatives to enhance validation processes and operational efficiency
  • Manage change control activities and assess validation impacts associated with process or system changes
  • Ensure adherence to data integrity requirements and governance standards across validation activities
  • Support regulatory inspections, customer audits, and quality assessments
  • Mentor, develop, and lead validation professionals while fostering a culture of accountability and excellence

Keys to Success:
Education
  • Advanced Degree with 8+ years of validation experience, or
  • Bachelor's Degree with 10+ years of validation experience
  • Preferred fields of study include Engineering, Chemistry, Biology, Life Sciences, or related technical disciplines

Experience
  • Significant experience in validation within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments
  • Experience coordinating, planning, executing, and approving validation activities across multiple disciplines
  • Demonstrated success managing complex validation projects, programs, and teams
  • Experience partnering with project managers to establish priorities and drive project execution
  • Experience participating in regulatory inspections and customer audits
  • Experience with validation master planning, change control systems, and quality management systems
  • Expertise in process validation and analytical instrument qualification
  • Proficiency in data integrity compliance, governance, and regulatory expectations related to data lifecycle management

Knowledge, Skills, Abilities
  • Strong knowledge of cGMP regulations, including FDA, EU, and global regulatory requirements
  • Expertise in equipment qualification, process validation, cleaning validation, computer system validation, utility qualification, and analytical instrument qualification
  • Strong understanding of ALCOA+ principles, data integrity requirements, and data governance practices
  • Proficiency in risk assessment methodologies and statistical analysis
  • Strong technical writing, documentation, and report review capabilities
  • Excellent leadership, communication, and interpersonal skills
  • Ability to influence stakeholders and collaborate effectively across functions and organizational levels
  • Knowledge of Lean Manufacturing and continuous improvement methodologies
  • Proficiency with Microsoft Office and standard business software applications
  • Strong organizational and problem-solving skills with the ability to manage multiple priorities

Relocation assistance is not provided
Must be legally authorized to work in the United States now or in the future without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Compensation and Benefits
The salary range estimated for this position based in New Jersey is $112,500.00-$168,750.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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