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Computer Systems Validation Jobs in New Jersey (NOW HIRING)

WuXi Biologics

Senior Engineer l, 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 ...

CYNET SYSTEMS

Validation Lead

Raritan, NJ · On-site

$50 - $55/hr

Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and separation contexts. * Experience in writing and executing documentation for all aspects of ...

Legend Biotech USA, Inc.

Key ResponsibilitiesExecute and support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems.Author and maintain validation documentation ...

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How much do computer systems validation jobs pay per hour?

As of Aug 31, 2026, the average hourly pay for computer systems 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 is computer systems validation?

Computer systems validation (CSV) is the process of ensuring that computer-based systems used in regulated industries, like pharmaceuticals and biotechnology, perform their intended functions consistently and reliably. This process involves documenting and testing systems to confirm they meet regulatory requirements, such as those set by the FDA. The goal is to ensure data integrity, product quality, and patient safety by minimizing the risk of system errors or failures. CSV typically includes activities like risk assessment, test planning, execution, and maintaining thorough records for audits.

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

To thrive in Computer Systems Validation, you need a solid understanding of regulatory requirements (such as FDA or EMA guidelines), software development life cycles, and risk management, often supported by a degree in life sciences, IT, or engineering. Experience with validation frameworks, documentation tools, and systems like GAMP 5 and knowledge of 21 CFR Part 11 compliance are typically required. Attention to detail, strong analytical thinking, and effective communication set professionals apart in this role. These skills and qualifications ensure validated systems are compliant, reliable, and support organizational quality and regulatory objectives.

What are some common challenges faced in a computer systems validation role, and how can they be addressed?

Professionals in Computer Systems Validation often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and coordinating with cross-functional teams. Staying updated through regular training and industry resources helps address compliance changes. Clear communication and collaboration with IT, Quality Assurance, and business stakeholders are essential for efficient validation processes. Utilizing validation lifecycle management tools and standardized templates can also streamline documentation and reduce errors.

What is the difference between Computer Systems Validation vs Quality Assurance Specialist?

AspectComputer Systems ValidationQuality Assurance Specialist
CertificationsGAMP, CSV-specific trainingISO 9001, Six Sigma
Work EnvironmentRegulated industries like pharma, biotechManufacturing, software, service sectors
Primary FocusEnsuring computer systems meet regulatory standardsEnsuring overall product/service quality
Common UsageValidation of software, hardware in complianceProcess audits, quality improvement

Computer Systems Validation and Quality Assurance Specialist roles overlap in ensuring compliance and quality. However, CSV focuses specifically on validating computer systems to meet regulatory standards, especially in pharma and biotech industries. Quality Assurance Specialists have a broader scope, overseeing overall quality processes across various sectors. Both roles require similar certifications and work environments but differ in their primary objectives and specific tasks.

What are popular job titles related to Computer Systems Validation jobs in New Jersey?

For Computer Systems Validation jobs in New Jersey, the most frequently searched job titles are:

What job categories do people searching Computer Systems Validation jobs in New Jersey look for?

The top searched job categories for Computer Systems Validation jobs in New Jersey are:

What cities in New Jersey are hiring for Computer Systems Validation jobs?

Cities in New Jersey with the most Computer Systems Validation job openings:

Computer Systems Validation jobs near you
Infographic showing various Computer Systems Validation job openings in New Jersey as of August 2026, with employment types broken down into 100% Full Time. Highlights an 67% In-person, and 33% Remote job distribution, with an average salary of $114,704 per year, or $55.1 per hour.

Computer System Validation (CSV) Engineer

Piscataway, NJ • On-site

Spadtek Solutions LLC
See more jobs at Spadtek Solutions LLCexternal

Other

Posted 4 days ago

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

Job Summary

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.
Required Qualifications
  • 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.
Preferred Qualifications
  • 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.

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