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Computer System Validation Csv Pharmaceutical Jobs in Edison, NJ

ClinDCast, LLC

CSV Consultant

Raritan, NJ · On-site

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV ... Experience in the pharmaceutical, biotechnology, or medical device industry. * Excellent ...

ClinDCast LLC

CSV Consultant

Raritan, NJ · On-site

$120 - $180/hr

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV ... Experience in the pharmaceutical, biotechnology, or medical device industry. * Excellent ...

ClinDCast LLC

CSV Consultant

Raritan, NJ · On-site

$45 - $50/hr

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV ... Experience in the pharmaceutical, biotechnology, or medical device industry. * Excellent ...

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 ...

CYNET SYSTEMS

Validation Lead

Raritan, NJ · On-site

$50 - $55/hr

Specific experience in the pharmaceutical, biotechnology, or medical device industry. * Experience ... Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and ...

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 the Pharmaceutical, biotechnology, or medical device industry. * Experience in FDA ...

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All JobsComputer System Validation Csv Pharmaceutical JobsComputer System Validation Csv Pharmaceutical Jobs in Edison, NJ

Computer System Validation Csv Pharmaceutical information

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$10

$56

$89

How much do computer system validation csv pharmaceutical jobs pay per hour?

As of Sep 5, 2026, the average hourly pay for computer system validation csv pharmaceutical in Edison, NJ is $56.23, according to ZipRecruiter salary data. Most workers in this role earn between $43.32 and $66.68 per hour, depending on experience, location, and employer.

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

What are popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Edison, NJ?

For Computer System Validation Csv Pharmaceutical jobs in Edison, NJ, the most frequently searched job titles are:

What cities near Edison, NJ are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities near Edison, NJ with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in Edison, NJ as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 14% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $116,965 per year, or $56.2 per hour.

Computer System Validation (CSV) Consultants

Resourcesys

Piscataway, NJ • On-site

Other

Posted 10 days ago

Job description


Job Title:- Computer System Validation (CSV) Consultants
Location:- Piscataway, NJ/Chicago, IL (Onsite)
Duration:- Contract to hire
Job Description

Responsibilities

  • Plan, author, execute, and maintain CSV documentation including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
  • Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications.
  • Validate systems including LIMS, SAP, CMMS/calibration platforms, and other GxP-regulated applications.
  • Partner with system owners, Quality, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state through change control and periodic reviews.
  • Conduct risk assessments and data-integrity assessments aligned with ALCOA+ principles.
  • Support audits, inspections, CAPAs, deviations, and remediation activitiesrelated to computerized systems.
  • Apply GAMP 5 and risk-based validation principles throughout the system lifecycle.
  • Support validation activities involvingCaliber LIMS, SAP QM/MM/PP, BMRAM or comparable CMMS/calibration systems where applicable.

Required Qualifications

  • 5+ years of Computer System Validation experience within a GxP-regulated environment.
  • Strong, demonstrable CSV experience specifically within Biotechnology/Biotech environments REQUIRED.
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols.
  • Strong working knowledge of 21 CFR Part 11, EU Annex 11, GxP, GAMP 5, and risk-based validation.
  • Experience validating at least two of the following:
    • Laboratory instruments
    • Manufacturing/engineering equipment
    • LIMS
    • SAP
    • CMMS/calibration systems
  • Experience working cross-functionally withQuality, IT, Laboratory, Manufacturing, and technical SMEs.
  • Bachelor's degree in Life Sciences, Engineering, IT, or equivalent relevant life-sciences laboratory experience.
  • Ability and willingness to work onsite 5 days per week.
  • Candidates must be interested and eligible for a contract-to-hire opportunity.

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