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Computer System Validation Jobs in Princeton, NJ

ZS

Validation Consultant

Princeton, NJ · On-site

$140K - $152K/yr

Bachelor's or Master's degree in Engineering, Science, Medical, or a related field. * 6 - 10 years of hands-on experience in Computer System Validation within GxP-regulated environments (GCP/GMP; FDA ...

Noblesoft Technologies

CSV Engineer

Raritan, NJ · On-site

... Computer System Validation (Based on the role selected) • Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. • Experience in ...

ZS

Validation Associate Consultant

Princeton, NJ · On-site

$112K - $123K/yr

Bachelor's or Master's degree in Engineering, Science, Medical, or a related field. * 3+ years of hands-on experience in Computer System Validation within GxP-regulated environments (GCP/GMP; FDA, EU ...

Amzur Technologies, Inc.

CSV Lead

Princeton, NJ · On-site

Experience in the pharmaceutical, biotechnology, or medical device industry * 10+ years of experience in Computer System Validation (CSV) * Experience in FDA and/or global regulated environments with ...

WuXi Biologics

Senior Engineer I, Validation

Cranbury, NJ · On-site

$73K - $117K/yr

Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. * Experience in the qualification of biologics ...

Catapult

Senior Validation Manager

Princeton, NJ · On-site

Validation activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system, cleaning, and manufacturing processes in an aseptic environment. In this role, you ...

Catapult

Senior Validation Manager

Princeton, NJ · On-site

Validation activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system, cleaning, and manufacturing processes in an aseptic environment. In this role, you ...

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Computer System Validation information

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How much do computer system validation jobs pay per hour?

As of Jun 28, 2026, the average hourly pay for computer system validation in Princeton, NJ is $57.44, according to ZipRecruiter salary data. Most workers in this role earn between $44.23 and $68.12 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 job?

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 is the salary of computer system validation?

The salary for a Computer System Validation specialist typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Certifications such as GAMP or CSV training can influence earning potential, and roles often require knowledge of regulatory standards like FDA or ISO.

What are the key skills and qualifications needed to thrive in the Computer System Validation position, 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.

What is the work of computer system validation?

Computer System Validation (CSV) is the process of ensuring that computer systems used in regulated environments function correctly and comply with industry standards. It involves documenting and testing software, hardware, and related processes to verify they meet specified requirements, often using validation protocols and tools. CSV is essential in industries like pharmaceuticals and healthcare to ensure data integrity and compliance with regulations such as FDA or GMP.

Is computer system validation a good field?

Computer System Validation (CSV) is a vital part of regulated industries like pharmaceuticals and biotech, ensuring that computer systems meet quality and compliance standards. It often requires knowledge of regulatory guidelines, validation protocols, and tools like GxP and 21 CFR Part 11. The field offers steady demand, opportunities for certification, and roles in quality assurance and compliance management.

Is CSV a skill?

In the context of Computer System Validation, CSV refers to Computer System Validation itself, which is a process rather than a skill. However, skills related to CSV include understanding validation protocols, regulatory requirements, and proficiency with validation tools and documentation. These skills are essential for professionals performing CSV tasks in regulated industries like pharmaceuticals and biotech.
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What job categories do people searching Computer System Validation jobs in Princeton, NJ look for? The top searched job categories for Computer System Validation jobs in Princeton, NJ are:
What cities near Princeton, NJ are hiring for Computer System Validation jobs? Cities near Princeton, NJ with the most Computer System Validation job openings:
Computer System Validation jobs near you

Validation Consultant

ZS

Princeton, NJ • On-site

$140K - $152K/yr

Full-time

Posted 21 days ago

Job description

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS.
The Validation Consultant is part of the Testing and QA Expertise Center that adopts the latest cutting-edge technologies, methods, and automation to drive enterprise testing efficiency.
What you'll do: Validation Consultant in the Testing and QA Expertise Center will...
  • Act as a trusted CSV/CSA advisor to client stakeholders, partnering with business, IT, QA, and compliance teams to design and sustain compliant, efficient validation programs.
  • Lead the end-to-end CSV lifecycle for GxP-regulated systems, including strategy definition, planning, execution, and audit readiness.
  • Draft, review, and approve validation deliverables such as Validation Plans, URS, FS, DS, Risk Assessments, IQ/OQ/PQ protocols and reports, Traceability Matrices, Error Logs, Configuration Documents, and Validation Summary Reports, ensuring compliance with 21 CFR Part 11, EU Annex 11, and global regulatory expectations.
  • Define and present validation strategies and POVs for modern technologies, including AI/ML models, GenAI-enabled systems, and R/Python-based analytics, and support their implementation in client environments.
  • Apply and advocate risk-based CSA approaches aligned with GAMP 5 (2nd Edition) to balance compliance, efficiency, and business value.
  • Oversee and coordinate testing and validation activities across unit, system, integration, UAT, performance, and regression testing.
  • Manage validation execution and traceability using tools such as JIRA, HP ALM (preferred), Solution Manager, Kneat, or equivalent platforms.
  • Provide SME support on GxP, CSV, CSA, data integrity, and regulatory compliance topics during audits, inspections, and client reviews.
  • Develop, review, and implement CSV SOPs, work instructions, and quality processes, ensuring alignment with global regulatory requirements.
  • Mentor and guide junior validation team members, supporting capability building and consistency across engagements.
  • Deliver training sessions on CSV, quality, and compliance practices to client users and internal teams.

What You'll Bring
  • Bachelor's or Master's degree in Engineering, Science, Medical, or a related field.
  • 6 - 10 years of hands-on experience in Computer System Validation within GxP-regulated environments (GCP/GMP; FDA, EU, MHRA).
  • Able to travel up to 20%
  • Strong practical knowledge of global regulations and guidelines, including 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, QSR, ISO 13485, HIPAA, and related standards.
  • Proven experience delivering full validation documentation and qualification activities (IQ/OQ/PQ/UAT) across Agile and traditional SDLC models.
  • Deep understanding of CSV/CSA risk assessments, including GxP, business, and functional risk analysis, system gap assessments, and remediation planning.
  • Strong awareness of evolving industry trends in CSV validation, with the ability to adapt validation strategies for GenAI and AI/ML-based systems.
  • Experience with automation concepts, including test automation frameworks and validation considerations for automated testing.
  • Hands-on exposure to data platforms and ETL validation, including SQL-based validation, data verification, and troubleshooting.
  • Experience working with Pharma/Biotech R&D systems, with a solid understanding of drug development processes from discovery through post-marketing.
  • Excellent client-facing skills, with the ability to articulate validation rationale, risk-based decisions, and compliance strategies to both technical and non-technical stakeholders.
  • Strong command of Good Documentation Practices (GDP) and quality systems implementation.
  • Proficiency in Microsoft Office tools (Excel, Word, PowerPoint).
  • Strong verbal and written communication skills, with confidence presenting to clients and leadership.
  • Ability to operate independently while collaborating effectively across global, cross-functional teams.
  • Fluency in English
  • Client-first mentality
  • Intense work ethic
  • Collaborative spirit and problem-solving approach

How you'll grow:
  • Cross-functional skills development & custom learning pathways
  • Milestone training programs aligned to career progression opportunities
  • Internal mobility paths that empower growth via s-curves, individual contribution and role expansions

Perks & Benefits:
At ZS, your growth matters. We offer a comprehensive total rewards package that supports your health and well-being, financial future, time away, and professional development. With robust skills-building programs, multiple career progression paths, internal mobility, and a deeply collaborative culture, you'll have the opportunity to do meaningful work, expand your capabilities, and thrive as part of a global community. For details on total rewards in United States, visit ZS US office locations | Where we work | ZS.
Hybrid working model:
We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.
Travel:
Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
Considering applying?
At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems-the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. Learn more about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive.
If you're eager to grow, contribute, and bring your unique self to our work, we encourage you to apply.
ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.
To complete your application:
Candidates must possess or be able to obtain work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.
NO AGENCY CALLS, PLEASE.
Find Out More At:
www.zs.com

About ZS

Sourced by ZipRecruiter

Industry

Business management consulting

Company size

10,000+ Employees

Headquarters location

Evanston, IL, US

Year founded

1983

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